19 September 2025 - Today, the FDA approved pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) for subcutaneous injection for adult and paediatric (12 years and older) solid tumour indications approved for the intravenous formulation of pembrolizumab (Keytruda, Merck).

Efficacy was evaluated in Study MK-3475A-D77, a randomised, multi-centre, open-label, active-controlled trial conducted in patients with treatment-naïve metastatic non-small cell lung cancer, in whom there were no EGFR, ALK, or ROS1 genomic tumour aberrations.

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