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Merck’s Keytruda inches toward another biomarker-based OK with latest priority review

Merck & Co.’s immuno-oncology competitors have tried, so far fruitlessly, to use the investigational biomarker tumor mutational burden to help them win approvals. But regulators apparently like what they’re seeing from Merck where TMB is concerned.
 
The FDA has awarded the pharma giant a priority review for the use of solo Keytruda in previously treated patients with high tumor mutational burdens, no matter where those tumors are in the body. The move will shorten the regulatory timeline, bringing the deadline for the agency’s verdict up to June 16.

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