Should the cancer drug Avastin be approved as a treatment for metastatic breast cancer? The FDA has been considering this question since the emotionally charged debate began last December, when the agency first proposed revoking the drug s indication for that use. As expected, on Wednesday, an FDA advisory panel voted unanimously to recommend the revocation, citing follow-up studies by the manufacturer, Roche, that showed that the drug did not significantly increase survival time.
The decision has upset many who saw Avastin as a means of buying extra time for those with breast cancer. Now, without FDA approval, most insurers will not pay for Avastin in breast cancer treatment. (However, a spokesman for the Centers for Medicare and Medicaid announced today that Medicare would cover the cost regardless of the FDA's decision.) The FDA had a very difficult job to do here, ACSH s Dr. Elizabeth Whelan observes. Yet she is in agreement with those who acknowledge that the emotional appeals of those affected by breast cancer shouldn t be the determining factor in a case where it is the efficacy of the drug itself that is in doubt. ACSH's Dr. Gilbert Ross, while acknowledging the emotionally fraught nature of the case, emphasizes that the life-saving potential of Avastin just doesn t warrant its approval for this particular usage. He notes the possibility that advances in pharmacogenomics determining specific genetic factors linked to drug responsiveness might someday be able to determine which patients are most likely to respond to a given drug, findings that could apply to Avastin.
ACSH s Dr. Josh Bloom, who also agrees with the FDA s decision, encourages readers to go to the widely read blog of long-time pharmaceutical research chemist Derek Lowe for an even-handed and intelligent analysis. Lowe s discussion is more comprehensive than we can be here.
