The European Commission has approved Merck’s new subcutaneous formulation of Keytruda, branded as KEYTRUDA SC, making it the first subcutaneous immune checkpoint inhibitor available in Europe. The new under-the-skin injection—administered in one minute every three weeks or two minutes every six weeks—is approved for all 33 Keytruda indications for adult patients.
The formulation combines pembrolizumab with berahyaluronidase alfa, a human hyaluronidase variant developed by Alteogen. Approval was supported by the pivotal 3475A-D77 trial in metastatic non-small cell lung cancer, which showed comparable pharmacokinetics and consistent response rates between the subcutaneous and intravenous versions.
Merck’s oncology head Dr. Marjorie Green said the faster, more flexible dosing option will broaden treatment choices and potentially expand access across healthcare settings.
The authorization covers all EU member states plus Iceland, Liechtenstein and Norway, following a positive CHMP opinion and similar FDA approval of the U.S. version, KEYTRUDA QLEX, earlier this year.