Merck & Co., Inc. — Keytruda FDA Review (BLA761467, ORIG 1, 2025)

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Merck's BLA 761467 seeks traditional approval for KEYTRUDA QLEX (subcutaneous pembrolizumab/berahyaluronidase alfa-pmph) for all currently approved solid tumor indications of intravenous pembrolizumab in adults and pediatric patients (≥12 years), with accelerated approval for TMB-high cancers. The FDA's multidisciplinary review, primarily based on Study MK-3475A-D77 in metastatic NSCLC, confirms comparable pharmacokinetics, efficacy, and safety between the subcutaneous and intravenous formulations. The subcutaneous formulation offers an alternative, convenient administration route. PK non-inferiority was demonstrated, and efficacy/safety profiles were consistent, with injection-site reactions being the main difference. The FDA generally agrees with the applicant's conclusions, supporting a favorable risk-benefit assessment for the subcutaneous formulation.

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