FDA accepts Merck application for expanded use of Keytruda

Under Priority Review status, the FDA accepts Merck’s (NYSE:MRK) supplemental marketing application seeking approval to use Keytruda (pembrolizumab) to treat adult and pediatric patients with unresectable or metastatic solid tumors 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 agency’s action date is June 16.

https://seekingalpha.com/news/3558870-fda-accepts-merck-application-for-expanded-use-of-keytruda