Merck & Co.’s Keytruda Gets Fighting Chance In TNBC

Successful KEYNOTE-522 Results May Sway FDA

May 13 2021

• By Alaric DeArment

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The company previously was unsuccessful securing accelerated approval based on complete response data, but event-free survival results may be more persuasive.

Cancer — Merck & Co. announced positive results for Keytruda in TNBC • Source: Shutterstock

With more definitive efficacy results in hand, Merck & Co., Inc. may have a real shot at securing US Food and Drug Administration approval for Keytruda (pembrolizumab) in triple-negative breast cancer (TNBC) after previous attempts to win accelerated approval based on surrogate endpoints failed. If approved, it could become a competitor to a fellow immune checkpoint inhibitor, Roche Holding AG subsidiary Genentech, Inc. ’s PD-L1-targeting antibody, Tecentriq (atezolizumab).

Merck & Co. said on 13 May that its Phase III KEYNOTE-522 study of PD-1 inhibitor Keytruda in the neoadjuvant...

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