FDA and Avastin: More Questions Than Answers

August 18, 2010

According to ONCOLOGY contributor, Debu Tripathy, MD, FDA's process for the final approval of Avastin for advanced breast cancer raises many questions about the standards on drug approval in this changing era of targeted therapy and personalized medicine.

According to ONCOLOGY contributor, Debu Tripathy, MD, FDA's process for the final approval of Avastin for advanced breast cancer raises many questions about the standards on drug approval in this changing era of targeted therapy and personalized medicine.

Read Dr. Tripathy's interesting and provocative take on the issue in this posting.

According to a commentary by Lee Schwartzberg, MD

Although these results [E2100, AVADO, and RIBBON-1] confirmed and extended the value of bevacizumab for many attendees at ASCO, the FDA’s Oncology Drug Advisory Committee (ODAC), which met in July 2010, drew very different conclusions from the same data. ODAC voted 12 to 1 to veto the indication of bevacizumab in the first-line treatment of MBC based on the “unfavorable risk/benefit ratio.” The lack of an overall survival difference was particularly influential to this decision.

Many breast cancer oncologists would disagree vehemently with ODAC, instead endorsing the concept that a 2.5-month median improvement in PFS was, in fact, a meaningful endpoint. Moreover, clinicians are adept at handling the modest increase in toxicity engendered by the addition of bevacizumab, and they believe that, clinically, there is little to no decrement in quality of life from adding this agent.

It remains to be seen whether the FDA will withdraw the approval of bevacizumab for MBC. If it does, there could be profound changes in the way other drugs are evaluated for this disease. With regard to other antiangiogenic agents in MBC, the future is uncertain.

Look for upcoming coverage as this important issue unfolds…