FDA Converts Pembrolizumab TMB-H Solid Tumor Indication to Traditional Approval
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The FDA has granted traditional approval for pembrolizumab, or pembrolizumab with berahyaluronidase alfa-pmph, in unresectable or metastatic TMB-H solid tumors. The tumor-agnostic indication, previously held under a faster pathway, now carries full traditional approval, with TMB-H defined as at least 13 mutations per megabase. The updated indication covers patients whose tumors are unresectable or have spread, regardless of tumor type, based on the biomarker threshold. For clinicians and developers, the key change is the formalized mutational burden cutoff of ≥13 mut/Mb anchoring patient selection. The approval stands as granted; further label changes or expanded use would require additional regulatory action.
Written by a model from the reports · updated 3 hours ago
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- fda.govPickFDA grants traditional approval for pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph for unresectable or metastatic TMB-H solid tumors with updated indication
The FDA has converted the indication for pembrolizumab, as monotherapy or with berahyaluronidase alfa-pmph, in unresectable or metastatic TMB-H solid tumors to traditional approval, with TMB-H now defined as at least 13 mut/Mb. The TMB-H threshold was raised from the previous 10 mut/Mb because efficacy supporting traditional approval was not confirmed in patients with TMB of 10 to below 13 mut/Mb.
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