FDA OKs Merck’s Keytruda for second application based on biomarker

The FDA approves Merck’s (NYSE:MRK) 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.

In May 2017, the agency approved the PD-1 inhibitor for adult and pediatric patients with solid tumors identified with a biomarker called microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).

https://seekingalpha.com/news/3583617-fda-oks-mercks-keytruda-for-second-application-based-on-biomarker