Unexpected findings from two major clinical trials regarding the effectiveness of Avastin in fighting breast cancer have reopened the debate about this medication. In November of 2011, the FDA revoked its conditional approval of bevacizumab, the generic name for Avastin, for advanced breast cancer. The reasons for denying approval were that the drug posed toxic risks and did not significantly improve survival rates. However, a study done in Germany and another done in the United States, both of which were published in "The New England Journal of Medicine" on January 26th, showed some promise for Avastin in the shrinking of tumors in early-stage breast cancers.
Even so, the serious side effects of Avastin remain a concern. Additionally, not enough follow-up time has elapsed to ascertain whether or not survival rates are boosted by use of the drug.
Alberto J. Montero, MD and Charles Vogel, MD of the University of Miami, authors of an editorial that accompanied the JAMA articles, called for a wait-and-see approach. MedPage Today quoted the editorial as saying: "If surrogate endpoints like progression-free survival in patients with metastatic breast cancer and pathological complete response in the neoadjuvant setting are ultimately predictive of survival benefits in earlier-stage disease, then the use of these surrogates in clinical research will be vindicated, and the FDA's decision to withdraw the indication of bevacizumab for metastatic breast cancer will be further called into question."
