FDA Grants Full Approval for Pembrolizumab in TMB-High Solid Tumors, Adjusts Eligibility

The U.S. FDA has granted traditional approval to pembrolizumab (Keytruda), including its subcutaneous formulation, for adult and pediatric patients with unresectable or metastatic TMB-high solid tumors. This action converts its accelerated approval, with the eligibility definition for TMB-H narrowed to at least 13 mutations per megabase. Efficacy was not confirmed for patients with TMB between 10 and less than 13 mut/Mb, impacting a specific patient population.