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# FDA Converts 1 Keytruda Indication to Full Approval
- URL: https://www.fdaweb.com/fda-converts-1-keytruda-indication-to-full-approval/
- Published: 2023-03-30T12:00:00.000Z
- Updated: 2026-09-14T18:22:47.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154103

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](https://www.merck.com/news/fda-converts-to-full-approval-indication-for-keytruda-pembrolizumab-for-certain-adult-and-pediatric-patients-with-advanced-microsatellite-instability-high-msi-h-or-mismatch-repair-deficient/?ref=fdaweb.com) 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.