FDA converts pembrolizumab approval for TMB-high tumors, raises threshold to ≥13 mutations/megabase

● REGULATORY

The FDA granted traditional approval for pembrolizumab in unresectable or metastatic TMB-high solid tumors, updating the definition from ≥10 to ≥13 mutations/megabase after efficacy was not confirmed in the 10 to <13 range. (FDA)