A first for Keytruda in triple-negative breast cancer
Nearly a decade after FDA drafted guidance to spur the development of new treatments for neoadjuvant triple-negative breast cancer, Merck’s Keytruda has shown the first positive results in a Phase III trial using pathological complete response as an endpoint.
The 2012 draft guidance proposed pCR -- defined as complete absence of residual invasive cancer in resected breast tissue and all sampled ipsilateral lymph nodes after drug therapy and surgery -- as a surrogate endpoint for accelerated approval in the neoadjuvant setting. It also proposed inclusion of disease-free survival (DFS) in trial designs as a co-primary endpoint that matures later (see "Jump-starting Triple-negative")...
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