Re: From the L&L Newsletter

[Guest guest]

Zavie:

Isn't it ironic that this blockbuster study was funded by Novartis which, of

course, makes both drugs.  Let's see:  which drug goes generic first and which

give Novartis years of added revenues at obscene prices?

Oh, and when will we see a double blind study of Sprycel v. Gleevec v.

Tasigna??? Who will fund that one???

And that's the rest of the story.................

Happy Holidays to All,

Carl

From: Zavie <zmiller@...>

Subject: [ ] From the L & L Newsletter

Date: Sunday, December 20, 2009, 8:16 AM

 

Best choice for chronic leukemia treatment may change

Newer drug outperforms Gleevec in trial

By <http://sciencenews. org/view/ authored/ id/57/name/ _Seppa>

Seppa

January

<http://sciencenews. org/view/ issue/id/ 51064/title/ January_2nd% 2C_2010%3B_

Vol

..177_%231> 2nd, 2010; Vol.177 #1 (p. 15)

<http://sciencenews. org/index/ generic> font_down

<http://sciencenews. org/index/ generic> font_upText Size

NEW ORLEANS - People fighting chronic myeloid leukemia got a double dose of

good news at the meeting of the American Society of Hematology.

The drug nilotinib, marketed as Tasigna, proved better than the reigning

frontline drug used against CML, a new study finds. " Based on these results,

we strongly believe that nilotinib may become the new standard of care in

newly diagnosed CML patients, " says Giuseppe Saglio, a hematologist at the

University of Turin in Italy.

Meanwhile, in those CML patients who fail to improve on either of these

medications, an old drug abandoned in the last decade now shows promise as a

rescue therapy, researchers reported.

Based on the first study, nilotinib may now supersede imatinib, sold as

Gleevec, a drug that has led to a sea change in treatment for CML over the

past decade (SN: 12/14/02, p. 371).

Before imatinib, the typical CML patient had roughly three years to live,

barring a bone marrow transplant. Now, more than four-fifths of patients who

have started on imatinib are still alive after seven years, according to

Novartis, the company that makes the drug. The availability of imatinib has

also lessened the need for bone marrow transplant, an operation that carries

risks, particularly for elderly people.

But imatinib isn't foolproof, and nilotinib was developed to improve upon

it. To test the drugs head to head, Saglio and a team of collaborators in 35

countries identified 846 recently diagnosed CML patients and randomly

assigned two-thirds to receive nilotinib and one-third to get imatinib.

After one year, 80 percent of those on nilotinib no longer had signs of an

incriminating genetic marker of CML on their white blood cells. Of those

getting imatinib, 65 percent were clear of this marker.

A closer examination of the patients' white blood cells, down to the

molecular level, found that 44 percent of those getting nilotinib but only

22 percent of the imatinib group had apparently cleared the cancer, says

Saglio, who presented the findings on December 8.

Nilotinib and a similar drug called dasatinib, marketed as,Sprycel, gained

regulatory approval in recent years as backup drugs for imatinib in CML

patients who could not tolerate imatinib's side effects or whose cancer had

worsened in spite of it. All three drugs disable a rogue enzyme called

BCR-ABL that removes the brakes on leukemia cells' growth (SN: 1/1/05, p.

14). A genetic mutation, called Philadelphia chromosome, results in the

production of this abnormal enzyme, which is responsible for nearly all

cases of CML.

" Fifteen years ago, the standard of care [for CML] was a bone marrow

transplant, a very, very toxic therapy - curative to some patients but

toxic, " says Emanuel, a physician at the University of Arkansas for

Medical Sciences in Little Rock. " Now the standard of care is comparing one

pill against another. Things have changed. "

Although neutralizing BCR-ABL has been a life-saver in the true sense, the

drugs aren't universally curative, notes Larson, a hematologist at

the University of Chicago, who coauthored the nilotinib study and worked on

an earlier trial testing imatinib.

In particular, another mutation has surfaced in some CML patients that makes

their leukemia cells resistant to all three of these drugs. In the other

study providing welcome news for CML patients, researchers reported that an

older drug called omacetaxine stopped the cancer in many of these high-risk

patients.

Omacetaxine is an injectable drug that had been tested against leukemia in

past decades but was shelved when imatinib came along. " It was displaced

because imatinib was so spectacular, " says Cortes, an internist at the

University of Texas M.D. Cancer Center in Houston.

Cortes and his colleagues gave omacetaxine to 81 patients who had ceased to

benefit from the other CML drugs. The median survival time for such patients

is about 20 months. In this study, 80 percent of the patients getting

omacetaxine were still alive at the 24-month point, said Cortes, who

presented the data on December 5.

Although it remains unclear how omacetaxine works, leukemia researchers are

heartened that it can provide at least some benefit in this group of

patients with the troublesome mutation. " There is reason to believe that

omacetaxine may also be effective against other subsets of CML where the

exact mechanism of resistance is unclear, " says Larson.

About 5,000 people are diagnosed with CML each year in the United States and

about 22,000 are currently living with it. Although these people have

benefited greatly, the story of CML may also have broader ramifications,

Emanuel says.

Scientists have argued for decades that knowing the genetics that underlie a

cancer or other disease could lead to better treatments. " CML is a fairly

simple cancer, " he says. " The story of imatinib, nilotinib and dasatinib

shows us that what scientists have been saying is correct - if we understand

the genetic basis of a disease we can make more rational drugs to cure it. "

Saglio reports the he has done consulting for Novartis and BMS, which make

nilotinib and dasatinib, respectively. Larson reports consulting for

Novartis.

Zavie (age 71)

67 Shoreham Avenue

Ottawa, Canada, K2G 3X3

dxd AUG/99

INF OCT/99 to FEB/00, CHF

No meds FEB/00 to JAN/01

Gleevec since MAR/27/01 (400 mg)

CCR SEP/01. #102 in Zero Club

2.8 log reduction Sep/05

3.0 log reduction Jan/06

2.9 log reduction Feb/07

3.6 log reduction Apr/08

3.6 log reduction Sep/08

3.7 log reduction Jan/09

3.8 log reduction May/09

3.8 log reduction Aug/09

4.0 log reduction Dec/09

e-mail: zmillersympatico (DOT) ca

Tel: 613-726-1117

Fax: 613-482-4801

Cell: 613-282-0204

ID: zaviem

[Guest guest]

Hi Carl,

The patent for Gleevec runs out in about 2015. Of course Novartis is

planning ahead. It will be interesting to see if they lower the price of

Tasigna. It will be unfortunate if CML treatment will be based on the

ability to pay for the medication and not the best drug for the disease.

Just look at the furor that NICE has caused in England. They have not

approved the use of Sprycel and Tasigna for CML patients for purely cost

reasons. In their minds a transplant option is cheaper than these drugs.

There have been comparisons between the 3 drugs, but not double blind. We

will only see such a trial if a Big Pharma will benefit from it.

Zavie

Tasigna Pricing and Availability

The price of Tasigna is approximately $5700

per month-similar to Gleevec (800 mg)

which is $5844 per month, according to

Novartis (the AWP for 400 mg is $2844 per

month). According to the Journal of the

National Cancer Institute, (Feb. 2007) the

average wholesale price for one month of

therapy with Sprycel is $3900. This apparent

pricing advantage for Sprycel may play a role

in therapeutic decision making if efficacy and

safety are seen as comparable between the two

products.

I

Zavie (age 71)

67 Shoreham Avenue

Ottawa, Canada, K2G 3X3

dxd AUG/99

INF OCT/99 to FEB/00, CHF

No meds FEB/00 to JAN/01

Gleevec since MAR/27/01 (400 mg)

CCR SEP/01. #102 in Zero Club

2.8 log reduction Sep/05

3.0 log reduction Jan/06

2.9 log reduction Feb/07

3.6 log reduction Apr/08

3.6 log reduction Sep/08

3.7 log reduction Jan/09

3.8 log reduction May/09

3.8 log reduction Aug/09

4.0 log reduction Dec/09

e-mail: zmiller@...

Tel: 613-726-1117

Fax: 613-482-4801

Cell: 613-282-0204

ID: zaviem

_____

From: [mailto: ] On Behalf Of Carl

Davies

Sent: December 20, 2009 9:09 AM

Subject: Re: [ ] From the L & L Newsletter

Zavie:

Isn't it ironic that this blockbuster study was funded by Novartis which, of

course, makes both drugs. Let's see: which drug goes generic first and

which give Novartis years of added revenues at obscene prices?

Oh, and when will we see a double blind study of Sprycel v. Gleevec v.

Tasigna??? Who will fund that one???

And that's the rest of the story.................

Happy Holidays to All,

Carl

From: Zavie <zmillersympatico (DOT) <mailto:zmiller%40sympatico.ca> ca>

Subject: [ ] From the L & L Newsletter

groups (DOT) <mailto:%40> com

Date: Sunday, December 20, 2009, 8:16 AM

Best choice for chronic leukemia treatment may change

Newer drug outperforms Gleevec in trial

By <http://sciencenews. org/view/ authored/ id/57/name/ _Seppa>

Seppa

January

<http://sciencenews. org/view/ issue/id/ 51064/title/ January_2nd%

2C_2010%3B_ Vol

..177_%231> 2nd, 2010; Vol.177 #1 (p. 15)

<http://sciencenews. org/index/ generic> font_down

<http://sciencenews. org/index/ generic> font_upText Size

NEW ORLEANS - People fighting chronic myeloid leukemia got a double dose of

good news at the meeting of the American Society of Hematology.

The drug nilotinib, marketed as Tasigna, proved better than the reigning

frontline drug used against CML, a new study finds. " Based on these results,

we strongly believe that nilotinib may become the new standard of care in

newly diagnosed CML patients, " says Giuseppe Saglio, a hematologist at the

University of Turin in Italy.

Meanwhile, in those CML patients who fail to improve on either of these

medications, an old drug abandoned in the last decade now shows promise as a

rescue therapy, researchers reported.

Based on the first study, nilotinib may now supersede imatinib, sold as

Gleevec, a drug that has led to a sea change in treatment for CML over the

past decade (SN: 12/14/02, p. 371).

Before imatinib, the typical CML patient had roughly three years to live,

barring a bone marrow transplant. Now, more than four-fifths of patients who

have started on imatinib are still alive after seven years, according to

Novartis, the company that makes the drug. The availability of imatinib has

also lessened the need for bone marrow transplant, an operation that carries

risks, particularly for elderly people.

But imatinib isn't foolproof, and nilotinib was developed to improve upon

it. To test the drugs head to head, Saglio and a team of collaborators in 35

countries identified 846 recently diagnosed CML patients and randomly

assigned two-thirds to receive nilotinib and one-third to get imatinib.

After one year, 80 percent of those on nilotinib no longer had signs of an

incriminating genetic marker of CML on their white blood cells. Of those

getting imatinib, 65 percent were clear of this marker.

A closer examination of the patients' white blood cells, down to the

molecular level, found that 44 percent of those getting nilotinib but only

22 percent of the imatinib group had apparently cleared the cancer, says

Saglio, who presented the findings on December 8.

Nilotinib and a similar drug called dasatinib, marketed as,Sprycel, gained

regulatory approval in recent years as backup drugs for imatinib in CML

patients who could not tolerate imatinib's side effects or whose cancer had

worsened in spite of it. All three drugs disable a rogue enzyme called

BCR-ABL that removes the brakes on leukemia cells' growth (SN: 1/1/05, p.

14). A genetic mutation, called Philadelphia chromosome, results in the

production of this abnormal enzyme, which is responsible for nearly all

cases of CML.

" Fifteen years ago, the standard of care [for CML] was a bone marrow

transplant, a very, very toxic therapy - curative to some patients but

toxic, " says Emanuel, a physician at the University of Arkansas for

Medical Sciences in Little Rock. " Now the standard of care is comparing one

pill against another. Things have changed. "

Although neutralizing BCR-ABL has been a life-saver in the true sense, the

drugs aren't universally curative, notes Larson, a hematologist at

the University of Chicago, who coauthored the nilotinib study and worked on

an earlier trial testing imatinib.

In particular, another mutation has surfaced in some CML patients that makes

their leukemia cells resistant to all three of these drugs. In the other

study providing welcome news for CML patients, researchers reported that an

older drug called omacetaxine stopped the cancer in many of these high-risk

patients.

Omacetaxine is an injectable drug that had been tested against leukemia in

past decades but was shelved when imatinib came along. " It was displaced

because imatinib was so spectacular, " says Cortes, an internist at

the

University of Texas M.D. Cancer Center in Houston.

Cortes and his colleagues gave omacetaxine to 81 patients who had ceased to

benefit from the other CML drugs. The median survival time for such patients

is about 20 months. In this study, 80 percent of the patients getting

omacetaxine were still alive at the 24-month point, said Cortes, who

presented the data on December 5.

Although it remains unclear how omacetaxine works, leukemia researchers are

heartened that it can provide at least some benefit in this group of

patients with the troublesome mutation. " There is reason to believe that

omacetaxine may also be effective against other subsets of CML where the

exact mechanism of resistance is unclear, " says Larson.

About 5,000 people are diagnosed with CML each year in the United States and

about 22,000 are currently living with it. Although these people have

benefited greatly, the story of CML may also have broader ramifications,

Emanuel says.

Scientists have argued for decades that knowing the genetics that underlie a

cancer or other disease could lead to better treatments. " CML is a fairly

simple cancer, " he says. " The story of imatinib, nilotinib and dasatinib

shows us that what scientists have been saying is correct - if we understand

the genetic basis of a disease we can make more rational drugs to cure it. "

Saglio reports the he has done consulting for Novartis and BMS, which make

nilotinib and dasatinib, respectively. Larson reports consulting for

Novartis.

Zavie (age 71)

67 Shoreham Avenue

Ottawa, Canada, K2G 3X3

dxd AUG/99

INF OCT/99 to FEB/00, CHF

No meds FEB/00 to JAN/01

Gleevec since MAR/27/01 (400 mg)

CCR SEP/01. #102 in Zero Club

2.8 log reduction Sep/05

3.0 log reduction Jan/06

2.9 log reduction Feb/07

3.6 log reduction Apr/08

3.6 log reduction Sep/08

3.7 log reduction Jan/09

3.8 log reduction May/09

3.8 log reduction Aug/09

4.0 log reduction Dec/09

e-mail: zmillersympatico (DOT) ca

Tel: 613-726-1117

Fax: 613-482-4801

Cell: 613-282-0204

ID: zaviem

[Guest guest]

Zavie:

As always you are the champion of CML patients. 

I grieve for the patients in the U.S. and other countries who do not have health

insurance and cannot even get a diagnosis let alone treatment.

It's a crazy system.

Best, Carl

From: Zavie <zmillersympatico (DOT) <mailto:zmiller% 40sympatico. ca> ca>

Subject: [ ] From the L & L Newsletter

groups (DOT) <mailto:% 40groups. com> com

Date: Sunday, December 20, 2009, 8:16 AM

Best choice for chronic leukemia treatment may change

Newer drug outperforms Gleevec in trial

By <http://sciencenews. org/view/ authored/ id/57/name/ _Seppa>

Seppa

January

<http://sciencenews. org/view/ issue/id/ 51064/title/ January_2nd%

2C_2010%3B_ Vol

..177_%231> 2nd, 2010; Vol.177 #1 (p. 15)

<http://sciencenews. org/index/ generic> font_down

<http://sciencenews. org/index/ generic> font_upText Size

NEW ORLEANS - People fighting chronic myeloid leukemia got a double dose of

good news at the meeting of the American Society of Hematology.

The drug nilotinib, marketed as Tasigna, proved better than the reigning

frontline drug used against CML, a new study finds. " Based on these results,

we strongly believe that nilotinib may become the new standard of care in

newly diagnosed CML patients, " says Giuseppe Saglio, a hematologist at the

University of Turin in Italy.

Meanwhile, in those CML patients who fail to improve on either of these

medications, an old drug abandoned in the last decade now shows promise as a

rescue therapy, researchers reported.

Based on the first study, nilotinib may now supersede imatinib, sold as

Gleevec, a drug that has led to a sea change in treatment for CML over the

past decade (SN: 12/14/02, p. 371).

Before imatinib, the typical CML patient had roughly three years to live,

barring a bone marrow transplant. Now, more than four-fifths of patients who

have started on imatinib are still alive after seven years, according to

Novartis, the company that makes the drug. The availability of imatinib has

also lessened the need for bone marrow transplant, an operation that carries

risks, particularly for elderly people.

But imatinib isn't foolproof, and nilotinib was developed to improve upon

it. To test the drugs head to head, Saglio and a team of collaborators in 35

countries identified 846 recently diagnosed CML patients and randomly

assigned two-thirds to receive nilotinib and one-third to get imatinib.

After one year, 80 percent of those on nilotinib no longer had signs of an

incriminating genetic marker of CML on their white blood cells. Of those

getting imatinib, 65 percent were clear of this marker.

A closer examination of the patients' white blood cells, down to the

molecular level, found that 44 percent of those getting nilotinib but only

22 percent of the imatinib group had apparently cleared the cancer, says

Saglio, who presented the findings on December 8.

Nilotinib and a similar drug called dasatinib, marketed as,Sprycel, gained

regulatory approval in recent years as backup drugs for imatinib in CML

patients who could not tolerate imatinib's side effects or whose cancer had

worsened in spite of it. All three drugs disable a rogue enzyme called

BCR-ABL that removes the brakes on leukemia cells' growth (SN: 1/1/05, p.

14). A genetic mutation, called Philadelphia chromosome, results in the

production of this abnormal enzyme, which is responsible for nearly all

cases of CML.

" Fifteen years ago, the standard of care [for CML] was a bone marrow

transplant, a very, very toxic therapy - curative to some patients but

toxic, " says Emanuel, a physician at the University of Arkansas for

Medical Sciences in Little Rock. " Now the standard of care is comparing one

pill against another. Things have changed. "

Although neutralizing BCR-ABL has been a life-saver in the true sense, the

drugs aren't universally curative, notes Larson, a hematologist at

the University of Chicago, who coauthored the nilotinib study and worked on

an earlier trial testing imatinib.

In particular, another mutation has surfaced in some CML patients that makes

their leukemia cells resistant to all three of these drugs. In the other

study providing welcome news for CML patients, researchers reported that an

older drug called omacetaxine stopped the cancer in many of these high-risk

patients.

Omacetaxine is an injectable drug that had been tested against leukemia in

past decades but was shelved when imatinib came along. " It was displaced

because imatinib was so spectacular, " says Cortes, an internist at

the

University of Texas M.D. Cancer Center in Houston.

Cortes and his colleagues gave omacetaxine to 81 patients who had ceased to

benefit from the other CML drugs. The median survival time for such patients

is about 20 months. In this study, 80 percent of the patients getting

omacetaxine were still alive at the 24-month point, said Cortes, who

presented the data on December 5.

Although it remains unclear how omacetaxine works, leukemia researchers are

heartened that it can provide at least some benefit in this group of

patients with the troublesome mutation. " There is reason to believe that

omacetaxine may also be effective against other subsets of CML where the

exact mechanism of resistance is unclear, " says Larson.

About 5,000 people are diagnosed with CML each year in the United States and

about 22,000 are currently living with it. Although these people have

benefited greatly, the story of CML may also have broader ramifications,

Emanuel says.

Scientists have argued for decades that knowing the genetics that underlie a

cancer or other disease could lead to better treatments. " CML is a fairly

simple cancer, " he says. " The story of imatinib, nilotinib and dasatinib

shows us that what scientists have been saying is correct - if we understand

the genetic basis of a disease we can make more rational drugs to cure it. "

Saglio reports the he has done consulting for Novartis and BMS, which make

nilotinib and dasatinib, respectively. Larson reports consulting for

Novartis.

Zavie (age 71)

67 Shoreham Avenue

Ottawa, Canada, K2G 3X3

dxd AUG/99

INF OCT/99 to FEB/00, CHF

No meds FEB/00 to JAN/01

Gleevec since MAR/27/01 (400 mg)

CCR SEP/01. #102 in Zero Club

2.8 log reduction Sep/05

3.0 log reduction Jan/06

2.9 log reduction Feb/07

3.6 log reduction Apr/08

3.6 log reduction Sep/08

3.7 log reduction Jan/09

3.8 log reduction May/09

3.8 log reduction Aug/09

4.0 log reduction Dec/09

e-mail: zmillersympatico (DOT) ca

Tel: 613-726-1117

Fax: 613-482-4801

Cell: 613-282-0204

ID: zaviem

[Guest guest]

Hi Zavie,

 

I haven't posted in many months. Just reading your latest post and thinking of

how much you add for everyone. Thank you so much. I am coming up on my 7th yr.

since dxd Feb. 2003.  Now on 400 mg. due to side effects. There is a girl I

went to high school with in NH and she has CML but went for a 100% bone marrow

transplant back around 2001. She learned 2 months ago she is positive again for

CML after all these years. She is now on 400 mg Gleevec. How sad after all she

went through. 

 

Merry Christmas and Happy New Year.

Moe, VT

dxd 2003

Zavie #608

From: Zavie <zmillersympatico (DOT) <mailto:zmiller% 40sympatico. ca> ca>

Subject: [ ] From the L & L Newsletter

groups (DOT) <mailto:% 40groups. com> com

Date: Sunday, December 20, 2009, 8:16 AM

Best choice for chronic leukemia treatment may change

Newer drug outperforms Gleevec in trial

By <http://sciencenews. org/view/ authored/ id/57/name/ _Seppa>

Seppa

January

<http://sciencenews. org/view/ issue/id/ 51064/title/ January_2nd%

2C_2010%3B_ Vol

..177_%231> 2nd, 2010; Vol.177 #1 (p. 15)

<http://sciencenews. org/index/ generic> font_down

<http://sciencenews. org/index/ generic> font_upText Size

NEW ORLEANS - People fighting chronic myeloid leukemia got a double dose of

good news at the meeting of the American Society of Hematology.

The drug nilotinib, marketed as Tasigna, proved better than the reigning

frontline drug used against CML, a new study finds. " Based on these results,

we strongly believe that nilotinib may become the new standard of care in

newly diagnosed CML patients, " says Giuseppe Saglio, a hematologist at the

University of Turin in Italy.

Meanwhile, in those CML patients who fail to improve on either of these

medications, an old drug abandoned in the last decade now shows promise as a

rescue therapy, researchers reported.

Based on the first study, nilotinib may now supersede imatinib, sold as

Gleevec, a drug that has led to a sea change in treatment for CML over the

past decade (SN: 12/14/02, p. 371).

Before imatinib, the typical CML patient had roughly three years to live,

barring a bone marrow transplant. Now, more than four-fifths of patients who

have started on imatinib are still alive after seven years, according to

Novartis, the company that makes the drug. The availability of imatinib has

also lessened the need for bone marrow transplant, an operation that carries

risks, particularly for elderly people.

But imatinib isn't foolproof, and nilotinib was developed to improve upon

it. To test the drugs head to head, Saglio and a team of collaborators in 35

countries identified 846 recently diagnosed CML patients and randomly

assigned two-thirds to receive nilotinib and one-third to get imatinib.

After one year, 80 percent of those on nilotinib no longer had signs of an

incriminating genetic marker of CML on their white blood cells. Of those

getting imatinib, 65 percent were clear of this marker.

A closer examination of the patients' white blood cells, down to the

molecular level, found that 44 percent of those getting nilotinib but only

22 percent of the imatinib group had apparently cleared the cancer, says

Saglio, who presented the findings on December 8.

Nilotinib and a similar drug called dasatinib, marketed as,Sprycel, gained

regulatory approval in recent years as backup drugs for imatinib in CML

patients who could not tolerate imatinib's side effects or whose cancer had

worsened in spite of it. All three drugs disable a rogue enzyme called

BCR-ABL that removes the brakes on leukemia cells' growth (SN: 1/1/05, p.

14). A genetic mutation, called Philadelphia chromosome, results in the

production of this abnormal enzyme, which is responsible for nearly all

cases of CML.

" Fifteen years ago, the standard of care [for CML] was a bone marrow

transplant, a very, very toxic therapy - curative to some patients but

toxic, " says Emanuel, a physician at the University of Arkansas for

Medical Sciences in Little Rock. " Now the standard of care is comparing one

pill against another. Things have changed. "

Although neutralizing BCR-ABL has been a life-saver in the true sense, the

drugs aren't universally curative, notes Larson, a hematologist at

the University of Chicago, who coauthored the nilotinib study and worked on

an earlier trial testing imatinib.

In particular, another mutation has surfaced in some CML patients that makes

their leukemia cells resistant to all three of these drugs. In the other

study providing welcome news for CML patients, researchers reported that an

older drug called omacetaxine stopped the cancer in many of these high-risk

patients.

Omacetaxine is an injectable drug that had been tested against leukemia in

past decades but was shelved when imatinib came along. " It was displaced

because imatinib was so spectacular, " says Cortes, an internist at

the

University of Texas M.D. Cancer Center in Houston.

Cortes and his colleagues gave omacetaxine to 81 patients who had ceased to

benefit from the other CML drugs. The median survival time for such patients

is about 20 months. In this study, 80 percent of the patients getting

omacetaxine were still alive at the 24-month point, said Cortes, who

presented the data on December 5.

Although it remains unclear how omacetaxine works, leukemia researchers are

heartened that it can provide at least some benefit in this group of

patients with the troublesome mutation. " There is reason to believe that

omacetaxine may also be effective against other subsets of CML where the

exact mechanism of resistance is unclear, " says Larson.

About 5,000 people are diagnosed with CML each year in the United States and

about 22,000 are currently living with it. Although these people have

benefited greatly, the story of CML may also have broader ramifications,

Emanuel says.

Scientists have argued for decades that knowing the genetics that underlie a

cancer or other disease could lead to better treatments. " CML is a fairly

simple cancer, " he says. " The story of imatinib, nilotinib and dasatinib

shows us that what scientists have been saying is correct - if we understand

the genetic basis of a disease we can make more rational drugs to cure it. "

Saglio reports the he has done consulting for Novartis and BMS, which make

nilotinib and dasatinib, respectively. Larson reports consulting for

Novartis.

Zavie (age 71)

67 Shoreham Avenue

Ottawa, Canada, K2G 3X3

dxd AUG/99

INF OCT/99 to FEB/00, CHF

No meds FEB/00 to JAN/01

Gleevec since MAR/27/01 (400 mg)

CCR SEP/01. #102 in Zero Club

2.8 log reduction Sep/05

3.0 log reduction Jan/06

2.9 log reduction Feb/07

3.6 log reduction Apr/08

3.6 log reduction Sep/08

3.7 log reduction Jan/09

3.8 log reduction May/09

3.8 log reduction Aug/09

4.0 log reduction Dec/09

e-mail: zmillersympatico (DOT) ca

Tel: 613-726-1117

Fax: 613-482-4801

Cell: 613-282-0204

ID: zaviem

[Guest guest]

For those who are outside of the United States, do you have to pay anything for

your treatments... Gleevec, etc?

Thanks,

Danny

-- Sent from my Palm Prē

Carl Davies wrote:

 

Zavie:

Isn't it ironic that this blockbuster study was funded by Novartis which, of

course, makes both drugs.  Let's see:  which drug goes generic first and which

give Novartis years of added revenues at obscene prices?

Oh, and when will we see a double blind study of Sprycel v. Gleevec v.

Tasigna??? Who will fund that one???

And that's the rest of the story.................

Happy Holidays to All,

Carl

From: Zavie & lt;zmiller@...>

Subject: [ ] From the L & amp;L Newsletter

Date: Sunday, December 20, 2009, 8:16 AM

 

Best choice for chronic leukemia treatment may change

Newer drug outperforms Gleevec in trial

By & lt;http://sciencenews. org/view/ authored/ id/57/name/ _Seppa>

Seppa

January

& lt;http://sciencenews. org/view/ issue/id/ 51064/title/ January_2nd%

2C_2010%3B_ Vol

177_%231> 2nd, 2010; Vol.177 #1 (p. 15)

& lt;http://sciencenews. org/index/ generic> font_down

& lt;http://sciencenews. org/index/ generic> font_upText Size

NEW ORLEANS - People fighting chronic myeloid leukemia got a double dose of

good news at the meeting of the American Society of Hematology.

The drug nilotinib, marketed as Tasigna, proved better than the reigning

frontline drug used against CML, a new study finds. " Based on these results,

we strongly believe that nilotinib may become the new standard of care in

newly diagnosed CML patients, " says Giuseppe Saglio, a hematologist at the

University of Turin in Italy.

Meanwhile, in those CML patients who fail to improve on either of these

medications, an old drug abandoned in the last decade now shows promise as a

rescue therapy, researchers reported.

Based on the first study, nilotinib may now supersede imatinib, sold as

Gleevec, a drug that has led to a sea change in treatment for CML over the

past decade (SN: 12/14/02, p. 371).

Before imatinib, the typical CML patient had roughly three years to live,

barring a bone marrow transplant. Now, more than four-fifths of patients who

have started on imatinib are still alive after seven years, according to

Novartis, the company that makes the drug. The availability of imatinib has

also lessened the need for bone marrow transplant, an operation that carries

risks, particularly for elderly people.

But imatinib isn't foolproof, and nilotinib was developed to improve upon

it. To test the drugs head to head, Saglio and a team of collaborators in 35

countries identified 846 recently diagnosed CML patients and randomly

assigned two-thirds to receive nilotinib and one-third to get imatinib.

After one year, 80 percent of those on nilotinib no longer had signs of an

incriminating genetic marker of CML on their white blood cells. Of those

getting imatinib, 65 percent were clear of this marker.

A closer examination of the patients' white blood cells, down to the

molecular level, found that 44 percent of those getting nilotinib but only

22 percent of the imatinib group had apparently cleared the cancer, says

Saglio, who presented the findings on December 8.

Nilotinib and a similar drug called dasatinib, marketed as,Sprycel, gained

regulatory approval in recent years as backup drugs for imatinib in CML

patients who could not tolerate imatinib's side effects or whose cancer had

worsened in spite of it. All three drugs disable a rogue enzyme called

BCR-ABL that removes the brakes on leukemia cells' growth (SN: 1/1/05, p.

14). A genetic mutation, called Philadelphia chromosome, results in the

production of this abnormal enzyme, which is responsible for nearly all

cases of CML.

" Fifteen years ago, the standard of care [for CML] was a bone marrow

transplant, a very, very toxic therapy - curative to some patients but

toxic, " says Emanuel, a physician at the University of Arkansas for

Medical Sciences in Little Rock. " Now the standard of care is comparing one

pill against another. Things have changed. "

Although neutralizing BCR-ABL has been a life-saver in the true sense, the

drugs aren't universally curative, notes Larson, a hematologist at

the University of Chicago, who coauthored the nilotinib study and worked on

an earlier trial testing imatinib.

In particular, another mutation has surfaced in some CML patients that makes

their leukemia cells resistant to all three of these drugs. In the other

study providing welcome news for CML patients, researchers reported that an

older drug called omacetaxine stopped the cancer in many of these high-risk

patients.

Omacetaxine is an injectable drug that had been tested against leukemia in

past decades but was shelved when imatinib came along. " It was displaced

because imatinib was so spectacular, " says Cortes, an internist at the

University of Texas M.D. Cancer Center in Houston.

Cortes and his colleagues gave omacetaxine to 81 patients who had ceased to

benefit from the other CML drugs. The median survival time for such patients

is about 20 months. In this study, 80 percent of the patients getting

omacetaxine were still alive at the 24-month point, said Cortes, who

presented the data on December 5.

Although it remains unclear how omacetaxine works, leukemia researchers are

heartened that it can provide at least some benefit in this group of

patients with the troublesome mutation. " There is reason to believe that

omacetaxine may also be effective against other subsets of CML where the

exact mechanism of resistance is unclear, " says Larson.

About 5,000 people are diagnosed with CML each year in the United States and

about 22,000 are currently living with it. Although these people have

benefited greatly, the story of CML may also have broader ramifications,

Emanuel says.

Scientists have argued for decades that knowing the genetics that underlie a

cancer or other disease could lead to better treatments. " CML is a fairly

simple cancer, " he says. " The story of imatinib, nilotinib and dasatinib

shows us that what scientists have been saying is correct - if we understand

the genetic basis of a disease we can make more rational drugs to cure it. "

Saglio reports the he has done consulting for Novartis and BMS, which make

nilotinib and dasatinib, respectively. Larson reports consulting for

Novartis.

Zavie (age 71)

67 Shoreham Avenue

Ottawa, Canada, K2G 3X3

dxd AUG/99

INF OCT/99 to FEB/00, CHF

No meds FEB/00 to JAN/01

Gleevec since MAR/27/01 (400 mg)

CCR SEP/01. #102 in Zero Club

2.8 log reduction Sep/05

3.0 log reduction Jan/06

2.9 log reduction Feb/07

3.6 log reduction Apr/08

3.6 log reduction Sep/08

3.7 log reduction Jan/09

3.8 log reduction May/09

3.8 log reduction Aug/09

4.0 log reduction Dec/09

e-mail: zmillersympatico (DOT) ca

Tel: 613-726-1117

Fax: 613-482-4801

Cell: 613-282-0204

ID: zaviem

[Guest guest]

in canada ontario, its free, the minute you know you have leukemia , you apply

for a disibility and its all paid for, , im jeanny,, my daughter natasha have

leukemia, cml

From: ddobrzenski@...

Date: Sun, 20 Dec 2009 15:09:53 -0600

Subject: Re: [ ] From the L & L Newsletter

For those who are outside of the United States, do you have to pay anything for

your treatments... Gleevec, etc?

Thanks,

Danny

-- Sent from my Palm Prº

Carl Davies wrote:

Zavie:

Isn't it ironic that this blockbuster study was funded by Novartis which, of

course, makes both drugs. Let's see: which drug goes generic first and which

give Novartis years of added revenues at obscene prices?

Oh, and when will we see a double blind study of Sprycel v. Gleevec v.

Tasigna??? Who will fund that one???

And that's the rest of the story.................

Happy Holidays to All,

Carl

From: Zavie & lt;zmiller@...>

Subject: [ ] From the L & amp;L Newsletter

Date: Sunday, December 20, 2009, 8:16 AM

Best choice for chronic leukemia treatment may change

Newer drug outperforms Gleevec in trial

By & lt;http://sciencenews. org/view/ authored/ id/57/name/ _Seppa>

Seppa

January

& lt;http://sciencenews. org/view/ issue/id/ 51064/title/ January_2nd%

2C_2010%3B_ Vol

177_%231> 2nd, 2010; Vol.177 #1 (p. 15)

& lt;http://sciencenews. org/index/ generic> font_down

& lt;http://sciencenews. org/index/ generic> font_upText Size

NEW ORLEANS - People fighting chronic myeloid leukemia got a double dose of

good news at the meeting of the American Society of Hematology.

The drug nilotinib, marketed as Tasigna, proved better than the reigning

frontline drug used against CML, a new study finds. " Based on these results,

we strongly believe that nilotinib may become the new standard of care in

newly diagnosed CML patients, " says Giuseppe Saglio, a hematologist at the

University of Turin in Italy.

Meanwhile, in those CML patients who fail to improve on either of these

medications, an old drug abandoned in the last decade now shows promise as a

rescue therapy, researchers reported.

Based on the first study, nilotinib may now supersede imatinib, sold as

Gleevec, a drug that has led to a sea change in treatment for CML over the

past decade (SN: 12/14/02, p. 371).

Before imatinib, the typical CML patient had roughly three years to live,

barring a bone marrow transplant. Now, more than four-fifths of patients who

have started on imatinib are still alive after seven years, according to

Novartis, the company that makes the drug. The availability of imatinib has

also lessened the need for bone marrow transplant, an operation that carries

risks, particularly for elderly people.

But imatinib isn't foolproof, and nilotinib was developed to improve upon

it. To test the drugs head to head, Saglio and a team of collaborators in 35

countries identified 846 recently diagnosed CML patients and randomly

assigned two-thirds to receive nilotinib and one-third to get imatinib.

After one year, 80 percent of those on nilotinib no longer had signs of an

incriminating genetic marker of CML on their white blood cells. Of those

getting imatinib, 65 percent were clear of this marker.

A closer examination of the patients' white blood cells, down to the

molecular level, found that 44 percent of those getting nilotinib but only

22 percent of the imatinib group had apparently cleared the cancer, says

Saglio, who presented the findings on December 8.

Nilotinib and a similar drug called dasatinib, marketed as,Sprycel, gained

regulatory approval in recent years as backup drugs for imatinib in CML

patients who could not tolerate imatinib's side effects or whose cancer had

worsened in spite of it. All three drugs disable a rogue enzyme called

BCR-ABL that removes the brakes on leukemia cells' growth (SN: 1/1/05, p.

14). A genetic mutation, called Philadelphia chromosome, results in the

production of this abnormal enzyme, which is responsible for nearly all

cases of CML.

" Fifteen years ago, the standard of care [for CML] was a bone marrow

transplant, a very, very toxic therapy - curative to some patients but

toxic, " says Emanuel, a physician at the University of Arkansas for

Medical Sciences in Little Rock. " Now the standard of care is comparing one

pill against another. Things have changed. "

Although neutralizing BCR-ABL has been a life-saver in the true sense, the

drugs aren't universally curative, notes Larson, a hematologist at

the University of Chicago, who coauthored the nilotinib study and worked on

an earlier trial testing imatinib.

In particular, another mutation has surfaced in some CML patients that makes

their leukemia cells resistant to all three of these drugs. In the other

study providing welcome news for CML patients, researchers reported that an

older drug called omacetaxine stopped the cancer in many of these high-risk

patients.

Omacetaxine is an injectable drug that had been tested against leukemia in

past decades but was shelved when imatinib came along. " It was displaced

because imatinib was so spectacular, " says Cortes, an internist at the

University of Texas M.D. Cancer Center in Houston.

Cortes and his colleagues gave omacetaxine to 81 patients who had ceased to

benefit from the other CML drugs. The median survival time for such patients

is about 20 months. In this study, 80 percent of the patients getting

omacetaxine were still alive at the 24-month point, said Cortes, who

presented the data on December 5.

Although it remains unclear how omacetaxine works, leukemia researchers are

heartened that it can provide at least some benefit in this group of

patients with the troublesome mutation. " There is reason to believe that

omacetaxine may also be effective against other subsets of CML where the

exact mechanism of resistance is unclear, " says Larson.

About 5,000 people are diagnosed with CML each year in the United States and

about 22,000 are currently living with it. Although these people have

benefited greatly, the story of CML may also have broader ramifications,

Emanuel says.

Scientists have argued for decades that knowing the genetics that underlie a

cancer or other disease could lead to better treatments. " CML is a fairly

simple cancer, " he says. " The story of imatinib, nilotinib and dasatinib

shows us that what scientists have been saying is correct - if we understand

the genetic basis of a disease we can make more rational drugs to cure it. "

Saglio reports the he has done consulting for Novartis and BMS, which make

nilotinib and dasatinib, respectively. Larson reports consulting for

Novartis.

Zavie (age 71)

67 Shoreham Avenue

Ottawa, Canada, K2G 3X3

dxd AUG/99

INF OCT/99 to FEB/00, CHF

No meds FEB/00 to JAN/01

Gleevec since MAR/27/01 (400 mg)

CCR SEP/01. #102 in Zero Club

2.8 log reduction Sep/05

3.0 log reduction Jan/06

2.9 log reduction Feb/07

3.6 log reduction Apr/08

3.6 log reduction Sep/08

3.7 log reduction Jan/09

3.8 log reduction May/09

3.8 log reduction Aug/09

4.0 log reduction Dec/09

e-mail: zmillersympatico (DOT) ca

Tel: 613-726-1117

Fax: 613-482-4801

Cell: 613-282-0204

ID: zaviem

[Guest guest]

>

> Zavie:

>

> Isn't it ironic that this blockbuster study was funded by Novartis which, of

course, makes both drugs.  Let's see:  which drug goes generic first and which

give Novartis years of added revenues at obscene prices?

>

> Oh, and when will we see a double blind study of Sprycel v. Gleevec v.

Tasigna??? Who will fund that one???

>

> And that's the rest of the story.................

>

> Happy Holidays to All,

> Carl

______________________________

Hi Carl,

I think 2 groups want this information for different reasons, so if the study

gets done and Novartis funds it....it gets done.

CML specialists want to know if one drug is working better than another and will

have better long term outcomes for their patients' benefit. From what you read,

if you were a newly diagnosed patient, would you want your onc to put you on

Gleevec or Tasigna?

Dr. Druker told me long ago that they might at some point in time consider

starting a patient on one of the newer, more potent 2nd generation TKI drugs

(Tasigna, Sprycel) and once the patient achieved a certain level of response,

use Gleevec as a maintenance drug (but that was when they thought it had fewer

side effects??? not so for many patients). As a generic down the road, it would

be cheaper.

I also just recently asked him whether he thought Tasigna or Sprycel was more

potent. You read that Tasigna is about 30x stronger than Gleevec and that

Sprycel is maybe 300x more potent that Gleevec. He said that he thought they

were about the same.....based on some complicated math. The usual Tasigna dose

is 800mg/day and the Sprycel dose in 100mg/day......so there is an 8 fold

difference right there in potency. They you have to consider how long the drug

is in the bloodstream (the half-life) and maybe some other factors......so he

thought the potency difference was negligent.

And about the cost of Tasigna in the US....I recently checked what it would cost

me to get it through Medicare Part D (Rx) and it is about $7200/month for 800mg.

So, maybe we should be getting our drugs through Canada.....but the Congress has

out-lawed that (can you believe claiming that the drug might not be as safe!!).

Happy Holidays everyone,

C.

[Guest guest]

> in canada ontario, its free, the minute you know you have leukemia , you

apply for a disibility and its all paid for, , im jeanny,, my daughter natasha

have leukemia, cml

>

***********************************************

Hi Jeanny,

It's actually only free in Ontario for people on Welfare. Others have to pay

various amounts depending on how much they earn and how much their insurance

covers (assuming they have insurance).

It can actually be quite a nightmare as people usually have to pay upfront for

the drug then wait to be reimbursed by either their insurance or the government

assistance program (Trillium) and that can sometimes take weeks or even months.

I know one patient who stopped taking Gleevec because he just couldn't keep up

with the thousands of dollars he was in debt while he waited to be reimbursed

for months past.

Tracey