Posted by Michael Wonder on 30 Mar 2023
FDA converts to full approval indication for Keytruda (pembrolizumab) for certain adult and paediatric patients with advanced microsatellite instability-high or mismatch repair deficient solid tumours
29 March 2023 - Merck today announced that the US FDA has granted full approval to Keytruda, Merck’s anti-PD-1 therapy, for the treatment of adult and paediatric patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient solid tumours, 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 2 KEYNOTE-158, KEYNOTE-164 and KEYNOTE-051 trials and includes data in 504 adult and paediatric 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 tumour type.
