FDA Converts 1 Keytruda Indication to Full Approval

FDA has converted from accelerated to full approval Merck’s Keytruda (pembrolizumab) to treat certain adult and pediatric patients with advanced microsatellite instability-high or mismatch repair deficient solid tumors. The full approval is for treating adult and pediatric patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient tumors as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.

Merck says the conversion from accelerated to full approval was based on results from the Phase 2 KEYNOTE-158, KEYNOTE-164, and KEYNOTE-051 trials that include data from 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,” Merck says.