Bendamustine

[Guest guest]

my husband qualified for this drug trial at Cornell, but our insurance won't cover it, we're in the process of appealing this decision as he has no other options right now. Any suggestion would be appreciated, thanks to all who respond, Judy in NY

[Guest guest]

Sorry my ignorance, but I thought if you qualify for a trial you do not have to pay and the Pharmaceutical company doing the trial should pay for it. After all they are going to be the ones making the money after the results come out.

Chonette

Re: Bendamustine

my husband qualified for this drug trial at Cornell, but our insurance won't cover it, we're in the process of appealing this decision as he has no other options right now. Any suggestion would be appreciated, thanks to all who respond, Judy in NY

[Guest guest]

I thought drug trials were paid for by the institution that conducts them!

Andy Gach

-- Re: Bendamustine

my husband qualified for this drug trial at Cornell, but our insurance won't cover it, we're in the process of appealing this decision as he has no other options right now. Any suggestion would be appreciated, thanks to all who respond, Judy in NY

[Guest guest]

They first file with your insurance co. and if they don't pay the drug co. will. Gach <unclewolf@...> wrote: I thought drug trials were paid for by the institution that conducts them! Andy Gach -- Re: Bendamustine my husband qualified for this drug trial at Cornell, but our insurance won't cover it, we're in the process of appealing this decision as he has no other options right now. Any suggestion would be appreciated, thanks to all who respond, Judy in NY

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[Guest guest]

In a message dated 10/2/2006 3:51:35 A.M. Eastern Daylight Time, chonette@... writes:

Sorry my ignorance, but I thought if you qualify for a trial you do not have to pay and the Pharmaceutical company doing the trial should pay for it. After all they are going to be the ones making the money after the results come out.

Yeah, you'd THINK but all the drug company would pay for is the actual drug, and reimbursement for parking and travel, we'd have to pay for all medical tests, infusion time/chair costs, doctor visits, etc. Would cost us thousands of dollars a month for eight months. That's what we couldn't understand, why should ANYTHING come out of our pockets or through our insurance when it's to help the drug company. Go figure.

[Guest guest]

In a message dated 10/2/2006 9:26:40 A.M. Eastern Daylight Time, unclewolf@... writes:

thought drug trials were paid for by the institution that conducts them!

Yup, the DRUG is but nothing else related to it such as infusion, tests, doc visits, etc. Oh, yeah, they DO reimburse for parking and travel. Nice, huh?

[Guest guest]

What a ripoff!

Re: Bendamustine

In a message dated 10/2/2006 9:26:40 A.M. Eastern Daylight Time, unclewolf@... writes:

thought drug trials were paid for by the institution that conducts them!

Yup, the DRUG is but nothing else related to it such as infusion, tests, doc visits, etc. Oh, yeah, they DO reimburse for parking and travel. Nice, huh?

[Guest guest]

Myellm,

Thanks for the explanation, I am not very knowledgeable on these matters. I am also sorry that people have to spend so much on test etc.

Chonette

Re: Bendamustine

In a message dated 10/2/2006 3:51:35 A.M. Eastern Daylight Time, chonetteenex (DOT) net writes:

Sorry my ignorance, but I thought if you qualify for a trial you do not have to pay and the Pharmaceutical company doing the trial should pay for it. After all they are going to be the ones making the money after the results come out.

Yeah, you'd THINK but all the drug company would pay for is the actual drug, and reimbursement for parking and travel, we'd have to pay for all medical tests, infusion time/chair costs, doctor visits, etc. Would cost us thousands of dollars a month for eight months. That's what we couldn't understand, why should ANYTHING come out of our pockets or through our insurance when it's to help the drug company. Go figure.

[Guest guest]

TREANDA (Bendamustine) has been around for long, but is now approved for CLL by the FDA.

FDA Accepts Cephalon, Inc. (CEPH) TREANDA ® New Drug Application for the Treatment of Relapsed Indolent Non-Hodgkin's Lymphoma 2/19/2008 6:49:49 AM

FRAZER, Pa., Feb. 19 /PRNewswire-FirstCall/ -- Cephalon, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's new drug application (NDA) for TREANDA® (bendamustine HCl) for Injection for the treatment of patients with indolent B-cell non-Hodgkin's lymphoma (NHL) who have progressed during or following treatment with rituximab or a rituximab-containing regimen. According to the National Cancer Institute, an estimated 30,000 people in the United States were expected to be diagnosed in 2007 with indolent NHL, a serious and slow growing cancer of the lymphatic system that is difficult to treat because patients are prone to relapse after treatment. Cephalon submitted the TREANDA application for relapsed indolent NHL in December 2007 and a decision from the FDA is expected by October 31, 2008.

"We are pleased that the application for TREANDA to treat relapsed indolent NHL is on track. With two NDAs for TREANDA pending review decisions, 2008 is a significant year for this product and bodes well for the future of Cephalon in oncology," said Dr. Lesley , Executive Vice President, Worldwide Medical and Regulatory Operations.

The TREANDA NDA for relapsed indolent NHL is supported by three studies in patients with NHL, including two single-agent studies and one in combination with rituximab. In these studies, patients treated with TREANDA had a high rate of response and a manageable and tolerable side effect profile, with adverse events similar to those observed with other chemotherapy agents such as myelosuppression (decrease in blood counts), nausea, and vomiting.

About TREANDA

TREANDA is a hybrid of a purine analog and an alkylator making it a novel chemotherapeutic agent. Preclinical data demonstrate that TREANDA acts in two distinct ways to kill cancer cells. TREANDA damages the DNA in cancer cells, which leads to cell death by a process known as apoptosis (programmed cell death) as well as by an alternate cell death (non-apoptotic) pathway known as mitotic catastrophe (a disruption of normal cell division). The precise mechanism of action of TREANDA in humans has not been fully characterized.

The protocol for the TREANDA NHL pivotal trial received special protocol assessment (SPA) approval from the FDA in February 2006. The SPA process allows for FDA evaluation and acceptance of a clinical trial protocol, including trial size, clinical endpoints and/or data analysis. In 2007, Cephalon filed a request for orphan drug status for TREANDA as a treatment for patients with relapsed indolent NHL and the company is in discussion with FDA about this application.

In September 2007, Cephalon submitted an NDA requesting approval of TREANDA for the treatment of patients with chronic lymphocytic leukemia (CLL), for which the FDA has granted priority review and orphan drug status; a decision by the FDA is expected by March 20, 2008.

Cephalon holds exclusive rights to market and develop TREANDA in the United States. TREANDA is licensed from Astellas Pharma GmbH. Bendamustine HCl, the active ingredient in TREANDA, is marketed in Germany by Astellas' licensee, Mundipharma International Corporation Limited, under the tradename RIBOMUSTIN®. In Germany, RIBOMUSTIN is indicated as a single-agent or in combination with other anti-cancer agents for indolent NHL, multiple myeloma, and CLL. SymBio Pharmaceuticals Ltd holds exclusive rights to develop and market bendamustine HCl in Japan and selected Asia Pacific Rim countries.

In Europe, Cephalon markets three additional oncology products in 19 countries.

About Cephalon, Inc.

Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and commercialization of innovative products in four core therapeutic areas: central nervous system, pain, oncology and addiction. A member of the Fortune 1000, Cephalon currently employs approximately 3,000 people in the United States and Europe. U.S. sites include the company's headquarters in Frazer, Pennsylvania, and offices, laboratories or manufacturing facilities in West Chester, Pennsylvania, Salt Lake City, Utah, and suburban Minneapolis, Minnesota. The company's European headquarters are located in Maisons-Alfort, France.Delicious ideas to please the pickiest eaters. Watch the video on AOL Living.

[Guest guest]

I am replying with Jim Chiello in mind though

others on the list may

find what I am about to report interesting.

I receive treatment at Sylvester Comprehensive Caner Center in Miami,

though most of my doctor's appointments and actual treatments take

place at their Deerfield Beach branch which is much closer to where I

live in South Florida.

When I became refractory to Fludarbine and Rituxan, I did some research

and came up with a plan to do Campath. But my treating oncologist was

not in favor nor was my consulting hematologist/oncologist--Dr.

Rosenblatt

the closest to a genuine CLL expert in South Florida. Dr. Rosenblatt

convinced

me that bendamustine would be a better bet.

I should point out that our own Dr. Furman was in favor of Campath

because

it is less myelosuppressive. Dr. Rosenblatt said the problem with

bendamustine

is that the recommended dose is much too high, and recommended we start

at

50 mg/mt2. Since I have always been a proponent of lower doses, I felt

that

Dr. Rosenblatt and I were on the same page.

So I went ahead and had a total of three cycles of bendamustine each 28

days

apart. I had nausea and diarrhea after every cycle for 10 days to as

long as two

weeks. By the end of the third cycle at the end of October, I had

chronic diarrhea

and felt half-sick virtually all the time, as well as experiencing much

more fatigue

than usual. I was also experiencing arrhythmia (irregular heart-beat)

We decided to discontinue the bendamustine altogether--too toxic for

limited

benefits.

Since the end of the 3rd cycle, I am still plagued by diarrhea (though

it is finally

a little better and I still feel half-sick most of the time. My lymph

nodes are

noticeably larger than before. And I now have this crushing fatigue and

lack of

physical energy. And to add insult to injury, I have developed a bad

case of

edema from the waist down, especially in the ankles and feet. Low

protein and

low albumin may be contributing to the problem. But my digestion

deteriorated

so much after the bendamustine, I tended to avoid foods that were

inherently

hard to digest like fats and protein.

So now it's back to the drawing board for me. I understand we are all

different and

that what works for one may not work for another. But I have to admit,

I'm sorry

I ever agreed to the bendamustine. It has robbed me of the relatively

good health

I had before taking it.

Would I recommend it to someone like Jim? Not a chance. There are too

many other

options to consider, several of which have less toxicity.

That's my take on bendamustine. Dr. Hamblin describes bendamustine as

mutton

dressed up as lamb. He may be right!

Lorenz

[Guest guest]

Dear Jim,Since you've now received different opinions about Bendamustine, sometimes just Googling something like: Bendaumustine, pros & cons will pull up helpful articles and links which you can compare now with Fred's and 's experience as well as what Dr. Furman has said. It's helped me a lot in the past.-Ellen D.