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Save Avastin from FDA

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kidzrn View Drop Down
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    Posted: Jul 23 2010 at 10:08pm

URGENT:     The FDA will make a final decision any day between now and September 17.  We need to make our voices heard.  Every patient will have a different response to Avastin, but every patient should have the right to choose.

 

Let breast cancer patients have the choice of a medicine that may hold our cancer at bay and allow us hope that we will be around when a cure is found.

 

Show your support for me and the thousands of metastatic breast cancer survivors who want the same opportunities as others to LIVE and beat the statistics.

 

 

Please join this group and also write a letter to the FDA and your congressmen.

 

Richard Pazdur, Director, Office of Oncology Drug Products, FDA

richard.pazdur@fda.hhs.gov

 

Patricia Keegan, Director, Division of Biologic Oncology Products, FDA

patricia.keegan@fda.hhs.gov


Thanks, Christi

 
christi

2006,TNBC,Gr3 dbl mast, 4AC/4T {NED 4/07}, Lung Met 4/08, Carbo, Avastin, Taxol/Taxotere (CAT)x4, Lung Surgery 9/08, then Avastin every 3 wks until 2012...NED since 2/09
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dmwolf View Drop Down
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Post Options Post Options   Thanks (0) Thanks(0)   Quote dmwolf Quote  Post ReplyReply Direct Link To This Post Posted: Jul 24 2010 at 1:35am
Will do, Christi.  Thanks for providing the links.   I know a lot of women, like you, who have  been helped by Avastin.   And of course it could be a life-saving drug for any one of roughly 40% of women currently NED or as yet undiagnosed who will go on to develop metastatic disease. It should remain available and covered by insurance.  (though of course more studies need to be done to figure out exactly who the responders are likely to be)
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DX 2/08@43 stg II IDC; gr2,0 nodes. Neoadj chemo, first ACx2 (fail) then CarboTaxotereX6(better). Lump, Rads done 11/08; Clodronate. False alarm queen: PetCT lung & TM marker. NED. PBM w/recon 9/10.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote polis Quote  Post ReplyReply Direct Link To This Post Posted: Jul 24 2010 at 11:51am
How involved are insurance companies involved in this decision?.If this is the case we should try a referendum. What about the position of other countries?. Is there any other refernece to thsi whole confusing situation with avastin.?. I heard something was being said in Canada. Any  thoughts?. Again this is such disturbing news. And they don't even explain why this drug is not good. because Over all survival criteria?. Like some posted  that criteria would put a lot of drugs out of the market.

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Post Options Post Options   Thanks (0) Thanks(0)   Quote mitymuffin Quote  Post ReplyReply Direct Link To This Post Posted: Jul 24 2010 at 12:14pm
This is what the Wall Street Journal said on July 19th:
"The difference in benefit between women being treated with Avastin plus chemo and chemo alone “is not clinically meaningful,” and side effects were more concerning in members of the Avastin group, the paper says. The risk-benefit ratio of adding Avastin “may not be considered favorable,” the FDA documents said."

I too would like to know if there is discussion in Canada regarding this drug.
Diag. Triple neg. 4/23/10 Stage IIB, 3.2cm, grade 3, 1/11 lymph nodes, lumpectomy 4/23/10, AC + T + Avastin, clinical trial 5103, Rads, age 59
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Post Options Post Options   Thanks (0) Thanks(0)   Quote suec Quote  Post ReplyReply Direct Link To This Post Posted: Jul 24 2010 at 6:38pm
on another thread Kat discusses Avastin in Australia
tnbc 3b: partial mas 5/06; 6 rounds FEC; 36 rad; 05/09-mets to bone; xeloda, avastin, zometa; gemzar & avastin; rads to hips; 8 mo on methotrexate+5fu; 5/11 mets to liver/lung; halevan fails;carb&Abrx
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Post Options Post Options   Thanks (0) Thanks(0)   Quote kidzrn Quote  Post ReplyReply Direct Link To This Post Posted: Jul 24 2010 at 11:55pm

Here's a C&P of the argument FOR approval for Avastin:

Another breast cancer expert approached by Medscape Medical News, Gabriel Hortobagyi, MD, FACP, professor of breast medical oncology at the University of Texas M.D. Anderson Cancer Center, who was present at the ODAC meeting, said: "This is an interesting development."

"Bevacizumab is clearly active in breast cancer, and there is more experience with this agent in metastatic breast cancer than with many, if not most, other agents evaluated for the metastatic breast cancer indication," he said. In 3 separate randomized trials, adding bevacizumab to various commonly used chemotherapy regimens resulted in significantly improved overall response rate and time to progression. These beneficial effects were consistently found in all 3 trials and in all subgroups examined, he pointed out.

"Anecdotally, bevacizumab combinations can produce dramatic responses in individual patients, and it is my clinical impression that responses of such quality are seldom seen with the same chemotherapy programs without bevacizumab. As a frequent user of this agent, I have also found that it is very well tolerated by the great majority of patients; in very few do I need to modify dose or schedule, and in even fewer do I need to discontinue treatment because of toxicities."

However, a "puzzling observation" in all 3 studies is the total absence of a survival benefit - "the survival curves of the control and bevacizumab arms were entirely superimposable," Dr. Hortobagyi said. It is difficult to demonstrate a significant survival benefit in first-line therapy of metastatic breast cancer, because such benefit is often diluted by multiple subsequent treatments and crossover designs, he explained, but "we often see some separation of the curves, even if the difference doesn't reach statistical significance."

"In the trials in question, and as you would expect simply by chance, some parts of the bevacizumab curves were slightly above and others slightly below the control-arm curves. While none of these differences (whether positive or negative) were statistically significant, the FDA reviewer elected to present them in an incredibly biased manner, where positive (but nonsignificant) survival differences were labeled 'no difference,' and negative (also nonsignificant) differences were labeled as favoring the placebo arm," Dr. Hortobagyi explained.

"This either denotes ignorance of common statistical methods or an underlying agenda to place the agent in an unfavorable perspective. There were other surprising statements made by the FDA reviewer attributing certain toxicities to bevacizumab, when in fact those toxicities are well recognized as being associated with the underlying chemotherapy. For instance, bowel perforations are a well-recognized complication of taxanes, especially docetaxel; angina and myocardial infarction are reported complications of capecitabine; and congestive heart failure is a well-known complication of anthracyclines (doxorubicin and epirubicin)," he continued.

"The FDA reviewer continuously referred to these complications as bevacizumab-related, creating an artificially high bevacizumab-related mortality rate in the minds of ODAC members," Dr. Hortobagyi said.

He summarized the outcome of the meeting as follows: "ODAC members found the benefit of bevacizumab insufficient in view of the toxicities listed by both the sponsor and the FDA reviewer, and based on that belief, they felt that the 2 new trials failed to confirm the encouraging results of E2100, and that there was insufficient efficacy to expand or even maintain the metastatic breast cancer indication of bevacizumab."

However, he added that "during the discussion, I got the strong impression that several ODAC members had a poor understanding of clinical trials and statistics (based on some of the questions that were somewhat bizarre!), and that very few had any experience using bevacizumab in the clinic. Otherwise, they would have known that the frequent toxicities reported on paper caused few symptoms and actually did not affect quality of life, and perhaps they would have seen the response and progression-free survival benefits in a different light."

"I thought that the discussion brought to light some issues in the process. The sponsor complied entirely with the FDA's requests when accelerated approval was granted; however, the FDA instructions were vague, and the 'magnitude of benefit' was never defined. Despite the fact that the FDA never requested prolongation of survival, much of the discussion by ODAC members was based on this lack of survival benefit. Therefore, there was a major disconnect between the FDA and ODAC," Dr. Hortobagyi explained.

"Ultimately, ODAC members acted on their understanding of the risk/benefit ratio of the drug, and recommended removal of the metastatic breast cancer indication. I think this was the wrong recommendation, although witnessing the process I can see how inadequate instruction by the FDA, unfamiliarity with the drug, and a biased presentation by the FDA reviewer led to this result," he said.

"I am concerned, in part, because this recommendation might remove an important treatment option from patients with metastatic breast cancer. I am also concerned because 'clinical benefit' remains poorly defined. This precedent will set many drugs currently under development up for failure. It would be important for the FDA to clearly define expectations from sponsors and provide clear guidance to ODAC members, so that disconnects such as those observed during this discussion stop happening," Dr. Hortobagyi told Medscape Medical News.

Dr. Perez reports serving on steering committees for Bayer HealthCare and Genentech, and on an independent monitoring committee for Novartis. Dr. Hortobagyi was at the meeting as a consultant to Genentech, for which he will receive an honorarium, and also had travel and accommodation paid for by the company; he has disclosed no other relevant financial relationships.

christi

2006,TNBC,Gr3 dbl mast, 4AC/4T {NED 4/07}, Lung Met 4/08, Carbo, Avastin, Taxol/Taxotere (CAT)x4, Lung Surgery 9/08, then Avastin every 3 wks until 2012...NED since 2/09
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mitymuffin View Drop Down
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Post Options Post Options   Thanks (0) Thanks(0)   Quote mitymuffin Quote  Post ReplyReply Direct Link To This Post Posted: Jul 25 2010 at 2:44pm
Christi,
Thank you for that posting. It is good to read something from an informed doctor.
Diag. Triple neg. 4/23/10 Stage IIB, 3.2cm, grade 3, 1/11 lymph nodes, lumpectomy 4/23/10, AC + T + Avastin, clinical trial 5103, Rads, age 59
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