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Avastin As Breast Cancer Treatment Rejected By FDA Panel
The popular drug Avastin has been rejected as a possible treatment for metastatic breast cancer by a health advisory panel in the United States - when they find out that the drug triggers damaging side effects, in addition to not being really effective.
The US Food and Drug Administration has recommended the approval of the drug as breast cancer medication be revoked; and the makers of the drug’s appeal has been rejected unanimously by the panel. The FDA called for the revocation of the drug’s approval because of the discovered chances for severe side effects and the drug’s poor effectiveness during studies conducted.
Genentech, currently under management of the pharmaceutical giant Roche, were the makers of the drug. And, they were treated to a two-day hearing this week, in front of the panel’s six members.
The opening day of the hearing featured physicians and patients who argued that the revocation of the drug is not necessary. Most of the patients were observed to be emotional during the hearing.
The Deputy Chief Medical Officer for the American Cancer Society, Dr. Len Lichtenfeld and a spectator during the hearing blogged that the patients and supporters, the few symptoms didn’t come as an issue - since many of them are still alive and are generally feeling well. He also discussed that they these people generally were didn’t contest Avastin because they find a significant treatment benefit in Avastin for breast cancer.
Dr. Lichtenfeld added that a different story was told by FDA. He mentioned that - after looking at the large number of patients who were treated with Avastin along standard chemotherapy - FDA claims that the clinical trials done and data retrieved thereafter showed that Avastin has no meaningful clinical benefit. Dr. Lichtenfeld then further said - that one FDA representative mentioned that they only needed one trial that could show any benefit from Avastin but no such trial became apparent - further saying that risks of side effects during such trial were considerable.
The main problem that the FDA seems to be facing in lieu of the drug’s rejection has been stated by Lichtenfeld on his blog stating that the decision FDA made will prove to be difficult, as the case involves a clash between emotion and science.
The Associated Press reported that the FDA commissioner Margaret Hamburg is the one who will have to make the final decision, regardless of what the advisory panel may have decided on. Also, the scheduling of another hearing by the FDA marks the difficulty related to the withdrawal of the approval of a known medication for cancer.
The FDA’s recommendation last December was not able to instantly affect patients of breast cancer who wanted to purchase the drug. In the same way, Avastin (or bevacizumab) has not been limited when it comes to colon, lung, brain and kidney cancer cases.
Prescription of Avastin can still be done by doctors, “off-label”. However, many say that insurance companies are unlikely to cover off-label use of the drug as it is very expensive. According to reports, Avastin costs $8,000 or more, every month.