SILVER SPRING, MARYLAND -An advisory committee to the US Food and Drug Administration (FDA) sided with this afternoon the organization, agreeing in a unanimous vote, 6-0, the drug Avastin should not be approved for breast cancer. Although the FDA has not at one with its advisory committee, in this case, it is likely to do so because it has taken a similar decision in December. Agency officials reiterated their case against Avastin yesterday.
Those who said the panel should reject Avastin cited several reasons, including insufficient evidence that the benefits of the drug in breast cancer outweigh the risks of toxicity. Furthermore, it does not help women live longer and have a better quality of life. Avastin was approved for breast cancer in 08 to prolong "progression-free survival," or living with tumors that are not growing.
"There is nothing we can hang our hats in these studies that would make me feel comfortable exposing patients to risk without proven benefit," said committee member FDA Mikkael Sekeres, a hematologist-oncologist at the Cleveland Clinic in Ohio.
Genentech, which makes Avastin, tried in vain today to convince the advisory committee of six members (five of which had already recommended that Avastin is not approved for breast cancer) for reframe the discussion. Company officials, who requested the hearing, said the debate about whether the benefits of Avastin has exceeded its risk was due to a difference in "the interpretation and communication." With 127 slides, they tried to build a case for Avastin in breast cancer, but failed.
Some members of the Advisory Committee emphasized a disadvantage in today's decision to strip the drug's label breast cancer: This could undermine the accelerated approval process under which Avastin has first obtained the FDA's blessing accelerated approval is a way to get drugs to the sickest patients faster, with clinical data. less. It is virtually unheard of for the FDA to reverse such approval. in this case, the FDA fact, agency officials said, after further study showed that the benefit was much less than originally thought.
Avastin will remain on the market; it is approved for several other cancers. But if the FDA follows the recommendation of the panel, insurance companies and Medicare would be much less likely to cover the high cost for breast cancer.
"I thirst for this drug," said Patricia Howard breast cancer patients who took Avastin and spoke at the hearing. She hopes to appeal to the FDA Commissioner Margaret Hamburg before the final decision is taken. "[I really thought] we were [win]."
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