Breast Cancer Drug Gets a Unanimous Thumbs Down

SILVER SPRING, MARYLAND—An advisory committee to the U.S. Food and Drug Administration (FDA) sided this afternoon with the agency, agreeing in a unanimous vote, 6-0, that the drug Avastin should not be approved for breast cancer. Although FDA doesn't have to side with its advisory committee, in this case it's likely to do so since it made a similar decision back in December. Agency officials reiterated their case against Avastin yesterday.

Those who said the panel should reject Avastin cited several reasons, including inadequate evidence that the drug's benefits in breast cancer outweighed its risks of toxicity. Furthermore, it did not appear to help women live longer or have a better quality of life. Avastin was originally approved for breast cancer in 2008 for prolonging "progression-free survival," or living with tumors that aren't growing.

"There is nothing we can hang our hat on in these studies that would make me feel comfortable exposing these patients to the risks without the proven benefit," said FDA committee member Mikkael Sekeres, a hematologist-oncologist at the Cleveland Clinic in Ohio.

Genentech, which makes Avastin, tried in vain today to convince the six-member advisory panel (five of whom had previously recommended that Avastin not be approved for breast cancer) to reframe the discussion. Company officials, who requested this hearing, said that the debate over whether Avastin's benefits exceeded its risks was due to a difference in "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 pointed to a downside in today's decision to strip the drug of its breast cancer label: This could undermine the accelerated approval process under which Avastin first got FDA's blessing. Accelerated approval is a way to get drugs to the sickest patients more quickly, with less clinical data. It's virtually unheard of for FDA to reverse such an approval. In this case, FDA did so, agency officials said, after subsequent studies showed that the benefit was much less than initially thought.

Avastin will stay on the market; it's approved for several other cancers. But if FDA follows the panel's recommendation, insurance companies and Medicare would be much less likely to cover its high cost for breast cancer.

"I was thirsty for that drug," said breast cancer patient Patricia Howard, who has taken Avastin and spoke at the hearing. She hopes to appeal to FDA Commissioner Margaret Hamburg before the final decision is made. "[I really thought] we were going to [win]."

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