Overview

• U.S. regulators approved subcutaneous pembrolizumab (Keytruda Qlex) for all solid tumor uses already authorized for the IV version in adults and in patients 12 and older.
• Europe’s CHMP issued a positive opinion for the subcutaneous formulation across adult indications and also backed a perioperative use for certain resectable head and neck cancers.
• The CHMP recommendations now go to the European Commission for final decisions expected in the fourth quarter of 2025.
• Regulatory moves were supported by the phase 3 3475A-D77 trial, which showed noninferior pharmacokinetics and comparable efficacy and safety to IV pembrolizumab in metastatic NSCLC.
• Merck says dosing can be completed in about one minute for 395 mg every three weeks or about two minutes for 790 mg every six weeks, with injection-site reactions uncommon and mostly mild.