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Merck's Keytruda Is First Checkpoint Inhibitor To Win US Approval Based On TMB Biomarker

 
• By Jessica Merrill

Merck has secured FDA approval for Keytruda for use in tumors with high tumor mutational burden, something Bristol's Opdivo and AstraZeneca's Imfinzi were not able to do in lung cancer.

Athlete in action of high jump.
Keytruda clears a bar for use in TMB-high tumors • Source: Shutterstock

Merck & Co. Inc.'s Keytruda (pembrolizumab) has secured a new tumor-agnostic indication from the US Food and Drug Administration for patients with unresectable or metastatic tumor mutational burden-high (TMB-H) solid tumors. Other PD-1/L1 inhibitors, including Bristol-Myers Squibb Co.'s Opdivo (nivolumab) and AstraZeneca PLC's Imfinzi (durvalumab) have both pursued high TMB in lung cancer without success.

The 16 June FDA approval was an accelerated approval based on retrospective analysis of data from 10 cohorts of patients with previously treated unresectable or metastatic solid tumors with TMB-H in KEYNOTE-158; continued approval may be contingent on confirmatory study results

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