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The FDA has converted pembrolizumab's (Keytruda) accelerated approval to full traditional approval for unresectable or metastatic tumor mutational burden-high (TMB-H) solid tumors — but with a catch. The TMB-H threshold has been raised from ≥10 to ≥13 mutations per megabase, after data failed to confirm benefit at the lower cutoff. Both IV and subcutaneous formulations (Keytruda Qlex) are now covered for eligible adult and pediatric patients.
The FDA has granted full traditional approval to pembrolizumab (Keytruda) and its subcutaneous formulation pembrolizumab/berahyaluronidase alfa-pmph (Keytruda Qlex) for adult and pediatric patients with unresectable or metastatic TMB-high solid tumors. This converts the accelerated approval first granted in June 2020 — but comes with an important update: the TMB-H definition has been tightened from ≥10 to ≥13 mutations per megabase (mut/Mb), as clinical efficacy could not be confirmed in patients with TMB between 10 and 12 mut/Mb.
The approval is backed by the phase 2 KEYNOTE-158 trial, which evaluated pembrolizumab across multiple previously treated solid tumor types. Patients must have progressed on prior systemic therapy and have no satisfactory alternative treatment options. Keytruda Qlex is approved for patients aged 12 and older.
By the Numbers:
Why it matters: This full approval narrows the eligible patient population but strengthens confidence in the biomarker-driven treatment approach. Oncologists will need to recheck TMB scores for patients previously identified under the lower threshold to confirm continued eligibility.
