FDA converts to full approval indication for Keytruda for certain adult and pediatric patients with advanced microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors
Merck Inc., known as MSD outside of the United States and Canada, announced that the FDA has granted full approval to Keytruda, Merck’s anti-PD-1 therapy, for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options
The conversion from an accelerated to a full (regular) approval is based on results from the Phase II KEYNOTE-158, KEYNOTE-164 and KEYNOTE-051 trials and includes data in 504 adult and pediatric patients across more than 30 types of cancer. This marks the first full approval for an immunotherapy based on a predictive biomarker, regardless of solid tumor type.
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