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3h ago

FDA Approves First Subcutaneous Keytruda for 38 Cancer Uses

The one-minute shot streamlines administration to offer greater flexibility for patients and clinics.

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Merck (MSD) has received approval from the US Food and Drug Administration (FDA) for the subcutaneous format of its best-selling oncology asset, Keytruda. Image credit: U.P.SD via ShutterStock.com.

Overview

  • Keytruda QLEX combines pembrolizumab with berahyaluronidase alfa, becoming the first FDA-cleared subcutaneous PD-1 therapy.
  • The injection can be delivered in about one minute every three weeks or two minutes every six weeks, replacing a roughly 30‑minute IV infusion.
  • A Phase 3 study in treatment‑naïve metastatic non‑small cell lung cancer showed similar response rates and no notable PFS or OS differences versus IV dosing.
  • Merck says U.S. availability is planned for late September 2025, and European regulators issued a positive opinion for the new route.
  • Pricing is expected to align with IV Keytruda while final details are pending, and analysts question how much the SC version can offset post‑2028 biosimilar pressure and IV combination constraints.