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FDA Accepts Merck/MSD’s BLA for SC Pembrolizumab; Decision Expected September 2025

Mar 27, 2025

On 27 March 2025, Merck (known as MSD outside the US and Canada) announced that the US FDA has accepted its Biologics Licence Application for subcutaneous pembrolizumab (pembrolizumab plus berahyaluronidase alfa), with indications across all previously approved solid tumour indications for Keytruda®.  The FDA has set a PDUFA, or target action, date of 23 September 2025.

Reuters has reported that Merck/MSD intends to launch SC pembrolizumab on 1 October 2025.  This aligns with Merck/MSD’s previously expressed expectations of a 2025 launch for the subcutaneous product.

According to Merck/MSD, the European Medicines Agency (EMA) has also validated an extension application to introduce a new pharmaceutical form and new route of administration for Keytruda®.