Jump-starting triple-negative

Comments are due next Monday on a draft guidance FDA hopes will spur development of targeted therapies for neoadjuvant triple-negative breast cancer. Companies and researchers are encouraged the agency is endorsing a new surrogate endpoint; however, they caution that a poor understanding of the biology of triple-negative disease is the bigger barrier to developing new drugs for this population.

The draft guidance, issued May 30, proposes the use of pathologic complete response (pCR) as a surrogate endpoint for accelerated approval in the neoadjuvant setting. The guidance defines pCR as complete absence of residual invasive cancer in resected breast tissue and all sampled ipsilateral lymph nodes after drug therapy and surgery...