Negative vote for Avastin could have implications for cancer drug approvals
This article was originally published in Scrip
Executive Summary
The strongly negative vote by the FDA's oncologic drugs advisory committee (ODAC) - and an expected FDA decision now to take the extremely rare step of revoking the accelerated approval of Roche's Avastin (bevacizumab) for the treatment of first-line metastatic breast cancer - could have significant implications not only for Roche and the world's best-selling cancer drug but also for future approvals of oncology drugs. The committee members felt that the clinical benefit of Avastin in breast cancer had not been confirmed by the post-marketing studies in the disease.