Fw: European Union Approves Tasigna as Front Line Therapy

[Guest guest]

January 3, 2011 — The European Commission has approved nilotinib (Tasigna;

Novartis) for the first-line treatment of chronic-phase Philadelphia

chromosome-positive (Ph+) chronic myeloid leukemia (CML) in adults.

The European Commission's action was based on results from ENESTnd (Evaluating

Nilotinib Efficacy and Safety in Clinical Trials of Newly Diagnosed Ph+ CML

Patients), an ongoing phase 3 study comparing nilotinib and the current standard

of care, imatinib (Gleevec; Novartis).

One-year data published in the New England Journal of Medicine

(2010;362:2251-2259) revealed significantly greater major molecular response

rates and complete cytogenetic response rates with nilotinib 600 mg/day than

with imatinib 400 mg/day (44% vs 22% and 80% vs 65%, respectively; P < .001 for

both comparisons).

Nilotinib also significantly delayed time to progression to accelerated phase or

blast crisis relative to imatinib (P = .01 and .004, respectively). These

findings were supported by 18-month follow-up data presented at the 2010

American Society of Clinical Oncology annual meeting.

" We are pleased that [nilotinib] is now approved for newly diagnosed Ph+ CML

patients in chronic phase in the member states of the European Union, " said

Hervé Hoppenot, president of Novartis Oncology, in a company news release. " With

this expanded indication, newly diagnosed patients can benefit from a Bcr-Abl

tyrosine kinase inhibitor that, according to pivotal data, surpassed the

standard of care [imatinib] in key measures of efficacy, including delaying

disease progression at 12 months. "

The recommended dose of nilotinib for newly diagnosed chronic-phase Ph+ CML is

300 mg taken twice daily. A once-daily dose of 200 mg is recommended for

patients requiring concomitant treatment with strong cytochrome P450 isoenzyme

3A4 (CYP 3A4) inhibitors; those with mild, moderate, or severe hepatic

impairment should initially receive 200 mg of nilotinib twice daily.

Dose interruptions and adjustments are required for corrected QT (QTc) interval

prolongation; neutropenia and thrombocytopenia; and severe elevations of serum

lipase/amylase, bilirubin, or hepatic transaminase levels. The effects of

nilotinib on QTc interval prolongation are increased by the coadministration of

food, strong CYP 3A4 inhibitors, and other QTc-prolonging drugs.

As reported by Medscape Medical News, nilotinib previously was approved for this

indication by the US Food and Drug Administration, Switzerland's Swissmedic, and

Japan's Ministry of Health, Labor, and Welfare. Nilotinib also is licensed in

more than 90 countries for the treatment of chronic- and accelerated-phase Ph+

CML in adult patients who are either resistant or intolerant to at least 1

previous therapy, including imatinib.

3, 2011 — The European Commission has approved nilotinib (Tasigna; Novartis) for

the first-line treatment of chronic-phase Philadelphia chromosome-positive (Ph+)

chronic myeloid leukemia (CML) in adults.

The European Commission's action was based on results from ENESTnd (Evaluating

Nilotinib Efficacy and Safety in Clinical Trials of Newly Diagnosed Ph+ CML

Patients), an ongoing phase 3 study comparing nilotinib and the current standard

of care, imatinib (Gleevec; Novartis).

One-year data published in the New England Journal of Medicine

(2010;362:2251-2259) revealed significantly greater major molecular response

rates and complete cytogenetic response rates with nilotinib 600 mg/day than

with imatinib 400 mg/day (44% vs 22% and 80% vs 65%, respectively; P < .001 for

both comparisons).

Nilotinib also significantly delayed time to progression to accelerated phase or

blast crisis relative to imatinib (P = .01 and .004, respectively). These

findings were supported by 18-month follow-up data presented at the 2010

American Society of Clinical Oncology annual meeting.

" We are pleased that [nilotinib] is now approved for newly diagnosed Ph+ CML

patients in chronic phase in the member states of the European Union, " said

Hervé Hoppenot, president of Novartis Oncology, in a company news release. " With

this expanded indication, newly diagnosed patients can benefit from a Bcr-Abl

tyrosine kinase inhibitor that, according to pivotal data, surpassed the

standard of care [imatinib] in key measures of efficacy, including delaying

disease progression at 12 months. "

The recommended dose of nilotinib for newly diagnosed chronic-phase Ph+ CML is

300 mg taken twice daily. A once-daily dose of 200 mg is recommended for

patients requiring concomitant treatment with strong cytochrome P450 isoenzyme

3A4 (CYP 3A4) inhibitors; those with mild, moderate, or severe hepatic

impairment should initially receive 200 mg of nilotinib twice daily.

Dose interruptions and adjustments are required for corrected QT (QTc) interval

prolongation; neutropenia and thrombocytopenia; and severe elevations of serum

lipase/amylase, bilirubin, or hepatic transaminase levels. The effects of

nilotinib on QTc interval prolongation are increased by the coadministration of

food, strong CYP 3A4 inhibitors, and other QTc-prolonging drugs.

As reported by Medscape Medical News, nilotinib previously was approved for this

indication by the US Food and Drug Administration, Switzerland's Swissmedic, and

Japan's Ministry of Health, Labor, and Welfare. Nilotinib also is licensed in

more than 90 countries for the treatment of chronic- and accelerated-phase Ph+

CML in adult patients who are either resistant or intolerant to at least 1

previous therapy, including imatinib.

http://www.medscape.com/viewarticle/735139

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THE YEAR IN MEDICINE FOR 2010 (SEE Slideshow of top stories of the year)

I think you will find this extremely interesting. I like the one about

chocolate being good for you. LOL

Something about ndm-1 is mentioned as well. Here is a website for you to read

about it. Very serious and there are no antibiotics to stop the spread of it.

http://www.ndm-1.net/

http://www.medscape.com/features/year-in-medicine/2010

Affordable Care Act coming in September

http://www.medscape.com/features/slideshow/healthcare-reform

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Alzheimer's disease is the most common cause of dementia. It is a terminal

degenerative disease resulting in progressive cognitive and behavioral

impairment. Alzheimer's disease affects approximately 5.2 million people in the

United States at a cost of roughly $84 billion per year. With a steadily

increasing American population aged 65 years and older, 7.7 million people are

predicted to suffer from Alzheimer's disease by 2030 and an estimated 11-16

million by 2050.

See brain in slideshow.

http://www.medscape.com/features/slideshow/alzheimers/

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Telltale signs of Melonoma

http://www.medscape.com/features/slideshow/mole-melanoma/

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American Academy of Pain Medicine (Opioids for Pain gaining in popularity to

ease

pain)

http://www.medscape.com/features/slideshow/aapm

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FYI,

Lottie Duthu