fda.gov· FDA·· 4 hours agoPickScore81
FDA grants traditional approval for pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph for unresectable or metastatic TMB-H solid tumors with updated indication
In brief
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.
Why it matters
The TMB-H threshold rises from ≥10 to ≥13 mut/Mb, and efficacy was not confirmed for 10 to <13 mut/Mb, clarifying the narrowed indication.
Source: fda.gov · fda.gov