Posted by Michael Wonder on 07 Apr 2020
Merck receives priority review from FDA for second application for Keytruda (pembrolizumab) based on biomarker, regardless of tumour type
7 April 2020 - Supplemental biologics license application accepted for Keytruda monotherapy in patients whose tumours are tumour mutational burden-high who have progressed following prior treatment.
Merck today announced that the U.S. FDA has accepted and granted priority review for a new supplemental biologics license application for Keytruda, Merck’s anti-PD-1 therapy. The application seeks accelerated approval of Keytruda monotherapy for the treatment of adult and paediatric patients with unresectable or metastatic solid tumours with tissue tumor mutational burden-high (TMB-H) ≥10 mutations/megabase, as determined by an FDA-approved test, who have progressed following prior treatment and who have no satisfactory alternative treatment options.
The FDA has set a Prescription Drug User Fee Act, or target action, date of 16 June 2020.
The application was based in part on results from the Phase 2 KEYNOTE-158 trial, which also supported Merck’s 2017 FDA approval for Keytruda as the first cancer treatment based on a biomarker, regardless of cancer type, in microsatellite instability-high or mismatch repair deficient solid tumours.
