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

Successful KEYNOTE-522 Results May Sway FDA

 
• By Alaric DeArment

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).

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Merck Set To Add Perioperative Head-And-Neck Cancer To Keytruda Label

 
• By Joseph Haas

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Akeso Wins US Approval For PD-1 Antibody In NPC, Partly On US Data

 
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J&J Looks To Overcome Drug-Delivery Limitations In Bladder Cancer With TAR-200

 
• By Alaric DeArment

The drug maker presented data from two cohorts of a pivotal Phase IIb study in NMIBC. Cost and ease of administration offer the potential to benefit the drug commercially.

Merck Set To Add Perioperative Head-And-Neck Cancer To Keytruda Label

 
• By Joseph Haas

With positive data versus radiation therapy in KEYNOTE-689, Merck & Co. files for approval in perioperative head and neck cancer, adding to additional claim in that cancer type.

Revolution’s Next KRAS Drug Shows Promise In NSCLC

 
• By Andrew McConaghie

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