Transcript: Avastin Podcast by Dr. Janet Woodcock
Dr. Janet Woodcock: I’m Dr. Janet Woodcock. I’m head of the Center for Drug Evaluation and Research at the FDA and we’re in charge of regulating all of the drugs on the market, the prescription drugs, the over-the-counter drugs, the generic drugs.
Christopher Kelly: Dr. Woodcock, what action did FDA take today?
Dr. Janet Woodcock: FDA recommended that the indication for Avastin’s use in metastatic breast cancer be removed from the drug label.
Christopher Kelly: Can you explain what Avastin is and how it got approved?
Dr. Janet Woodcock: Well, Avastin is a cancer drug that is thought to work by blocking the growth of blood vessels into the tumor. Avastin is approved for a number of different cancers but in 2008, FDA also approved it for metastatic breast cancer under the accelerated approval regulations, which allows us to approve promising drugs for an indication that then, have to show after marketing that they have a clinical benefit. Those trials were done and the agency determined that although Avastin looked promising in the original trial, the subsequent trials did not confirm that magnitude of benefit.
Christopher Kelly: If FDA originally approved it, why is it now recommending to withdraw Avastin’s indication for breast cancer?
Dr. Janet Woodcock: Well, we did this because of the results of the confirmatory studies that showed that Avastin when it was added to the standard chemotherapy for medicine that if breast cancer did not improve survival and there was no evidence that the patients had clinical benefits, for example, on symptoms; therefore, we are proposing to remove the indication because the original promise of benefit was not confirmed in these subsequent trials.
Christopher Kelly: What does removing Avastin’s indication mean for women with breast cancer?
Dr. Janet Woodcock: Well the drug, Avastin, is not being removed from the market so it will remain marketed in the United States because it’s indicated for other cancers. For women who are currently taking Avastin for metastatic breast cancer, we feel that should be between them and their oncologist about whether to continue on the drug considering whether they feel they have benefited. We certainly empathize with patients who are trying to cope with metastatic breast cancer. There are several FDA approved therapies that prolong survival in people with metastatic breast cancer and that, of course, is the goal of treatment is either cure or prolong the survival of these patients.
Christopher Kelly: What happens next?
Dr. Janet Woodcock: FDA is very open to additional studies of this drug in metastatic breast cancer. I think all of the community is interested in trying to find a marketer that would identify those patients who might benefit from the drug and if that were the case, then a new indication could be put on the label for Avastin. I’d like to assure the public that FDA remains committed to working with drug developers in small companies and large companies, and with the academic community to identify new treatments for serious and life-threatening diseases including metastatic breast cancer and to get those products on the market and in the hands of doctors and patients so that they can benefit.