FDA death panel pulls the plug on breast cancer drug

FDA death panel pulls the plug on breast cancer drug
Posted by Staff

The Wall Street Journal reports:
Yesterday the Food and Drug Administration moved to revoke its regulatory approval of Avastin for metastatic breast cancer. Withdrawing a cancer treatment is almost never done, and though the decision was expected, that does not make it any less reprehensible.
The FDA said in a statement that it is removing Avastin's breast cancer indication because the biologic does not provide "a sufficient benefit in slowing disease progression to outweigh the significant risk to patients." Ponder that "sufficient." The agency is substituting its own judgments about clinical meaningfulness for those of practicing oncologists and terminally ill cancer patients.
The risks of Avastin are real, but manageable. Clinical trials do not show that the drug extends life overall in the aggregate, but they have shown that it allows women to live longer without their disease getting worse. Avastin improves progression-free survival by about four months on average. Different patients respond differently, and the drug is far more effective in some than in others, for reasons that researchers still do not understand. There aren't any perfect therapeutic options in end-stage oncology, and Avastin ought to have remained one of them.
Looking at the same data, the European Medicines Agency-the FDA's counterpart in the European Union-decided on Thursday that it would continue to approve Avastin for breast cancer in combination with chemotherapy. In October, the U.S. National Comprehensive Cancer Network-a consortium of 21 leading cancer centers that issues evidence-based medical guidelines-reaffirmed its position that Avastin is valuable in some cases.