FDA Delays Avastin Approval for Breast Cancer: Genentech Withholds FDA Letter

by Barbara Brenner

Avastin (bevacizumab) is an angiogenesis inhibitor (it stops tumors from developing a blood supply, theoretically limiting the spread of cancer) developed by Genentech. It is approved for colon cancer and non-small-cell lung cancer. The company is also seeking approval for use of the drug in metastatic breast cancer. A National Cancer Institute-sponsored clinical trial, E2100, focused on progression-free survival in women with advanced breast cancer treated with Avastin and standard chemotherapy. Genentech was hopeful that the trial would result in approval of Avastin for metastatic breast cancer.

However, in early September, the FDA wrote a letter to the company stating that approval consideration would be delayed until the company provided additional data. In particular, it seems that the FDA wants an independent review—performed by doctors who were not involved in the trial—of patient scans used to determine disease progression. However, at press time, Genentech had refused to release the letter—and the FDA is unable to—so the public is left wondering about its contents.

In a press release distributed to the advocacy community, Genentech claimed surprise at the FDA’s action, which could delay approval of the drug for the breast cancer market by as much as a year.1 In response, a number of advocacy organizations (many of them funded at least in part by Genentech) expressed outrage at the FDA decision to ask for more data. BCA, however, doesn’t believe that it’s necessarily a bad thing to delay approval of Avastin for metastatic breast cancer in order to ensure safety and efficacy.

But the FDA’s action raises several critical issues—about the relationship between the NCI and the FDA in the drug approval process, the standards that should be applied by the FDA when an expanded label is sought for an approved drug, appropriate end-points in drug trials, and what information the public and the patient community is entitled to have when a delay occurs in the drug approval process.

A group of long-time cancer advocates wrote an open letter to the FDA and NCI posing a series of questions about the FDA’s action in the Avastin case, the NCI’s role, and the need for broader public involvement on the important issues surrounding the drug approval process. (Read the letter online) BCA is working with these advocates and others to get answers to the critical questions that arise out of the Avastin case, but implicate the entire drug approval process.

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1 Genentech press release, “Genentech Receives Complete Response Letter From FDA for Avastin in Metastatic Breast Cancer,” September 11, 2006. Available online at www.gene.com/gene/news/press-releases.

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