Biologic response modifiers may be candidates for accelerated approval, FDA panel agrees.

Executive Summary

BIOLOGIC RESPONSE MODIFIERS MAY BE CANDIDATES FOR ACCELERATED APPROVAL based on response rates that show meaningful benefit over existing therapies, even though biologic responses may be slower than responses with traditional cytotoxic agents, FDA's Biological Response Modifiers Advisory Committee concluded Oct. 21. The FDA meeting was convened to discuss whether biologics are appropriate for accelerated approval even though they shrink tumors by different mechanisms of action from traditional cytotoxic agents.