Accelerated drug approval: FDA may get tougher; companies cite hurdles.

摘要

The U.S. Food and Drug Administration's Oncology Drugs Advisory Committee (ODAC), at its February meeting, urged the agency to raise its standards for granting experimental cancer drugs accelerated approval on the basis of surrogate markers. ODAC also called on drug developers to conduct more tests more rapidly to determine whether drugs given accelerated approval actually extend life. The 16-member committee concluded that single-arm trials, which were used to justify more than half the accelerated approvals since the program's inception in 1992, should be accepted only for rare cancers or when the evidence of efficacy from a single-arm trial was overwhelmingly positive (this happened with imatinib[Gleevec] for Philadelphia chromosome-positive chronic myeloid leukemia). The committee also reached a consensus-no votes took place at the -meeting-that the FDA should require at least two controlled trials as final proof of efficacy and recommended that those trials should be under way when accelerated approval is granted.