FDA Puts Off Avastin Decision

The Food & Drug Administration (FDA) has put off deciding whether or not Avastin should be approved as breast cancer treatment. According to The New York Times, the FDA decided to postpone a ruling until December after the maker of the cancer drug – Roche unit Genentech – submitted new information on <"http://www.yourlawyer.com/practice_areas/defective_drugs">Avastin.

Avastin, the best selling cancer drug in the world, was the first approved therapy designed to inhibit angiogenesis, the process by which new blood vessels develop and carry vital nutrients to a tumor. It was originally approved in 2004 to treat metastatic colon cancer, and in 2006, the agency approved it as a treatment for non-small cell lung cancer. In 2008, the FDA also approved Avastin as a metastatic breast cancer treatment in combination with a chemotherapy drug called paclitaxel, and in May 2009, it was approved to treat glioblastoma multiforme, an incurable brain cancer.

Avastin’s breast cancer indication was granted under an accelerated process that was based on initial positive studies. Companies then have to submit additional data to gain full approval. Avastin’s provisional approval for breast cancer was based on an initial trial that showed it lengthened the time until the disease worsened, though it did not prolong the women’s lives by a statistically significant amount. When the FDA initially approved Avastin as a treatment for breast cancer, it did so against the recommendation of an advisory panel.

Since then, two new studies failed to show the same ability to delay disease progression. They also indicated that women being treated with Avastin were more likely to suffer from a variety of potentially serious side effects, including blood clots, bleeding and heart failure. Those additional studies prompted an FDA advisory panel to recommend in July that approval of Avastin to treat breast cancer be rescinded. The vote for revocation was 12-1.

The FDA was supposed to make decision on Genentech’s application to expand the approval of Avastin for breast cancer by September 17, though there is no deadline on the decision on whether to rescind its provisional approval, the Times said.

According to the Times, Genentech declined to state what new information it had submitted to the FDA. However, it is known that research is under way to find genetic variations that might predict whether a patient would benefit from the drug, and that type of information could impact the FDA’s decision.

For now, the approval status for Avastin is unchanged. If the FDA does revoke Avastin’s provisional breast cancer approval, it would remain on the market, as it is approved for other cancers. And doctors would still be legally able to prescribe it “off label” to breast cancer patients – at least to those who could afford its $8,000 a month price tag. It is likely, however, that in such a case, insurers would refuse to pay for the drug as a breast cancer treatment.

This entry was posted in Pharmaceuticals. Bookmark the permalink.

© 2005-2019 Parker Waichman LLP ®. All Rights Reserved.