FDA Grants Traditional Approval to Keytruda for TMB-H Solid Tumors with Updated Mutation Threshold

The U.S. Food and Drug Administration (FDA) has granted traditional approval to Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) for adults and children with certain unresectable or metastatic solid tumors that have a high tumor mutational burden (TMB-H) and have progressed after prior treatment. This decision converts Keytruda's previous accelerated approval to traditional approval and updates the TMB-H threshold for eligible patients from at least 10 mutations per megabase to at least 13 mutations per megabase. This change follows confirmatory data that did not establish sufficient efficacy for patients with TMB between 10 and fewer than 13 mutations per megabase.