FDA Expands Keytruda Approval with Subcutaneous Formulation for Non-Small cell Lung Cancer
September 20, 2025 – The Food adn Drug Governance (FDA) today approved the use of pembrolizumab (keytruda), administered via subcutaneous injection, for patients with non-small cell lung cancer (NSCLC). This marks the first approval of a subcutaneous formulation of Keytruda for NSCLC, offering a potentially more convenient administration option compared too the current intravenous (IV) infusion.
The approval broadens access to Keytruda, a checkpoint inhibitor already widely used in NSCLC treatment, and addresses a meaningful need for patient convenience. Currently, NSCLC patients typically receive keytruda via IV infusion, requiring visits to a healthcare facility. The subcutaneous formulation allows for administration in a clinical setting or potentially at home,reducing treatment burden and improving quality of life. This change is particularly impactful for the approximately 236,790 Americans expected to be diagnosed with lung cancer in 2025, according to the American Cancer Society.
The FDA’s decision is based on data from clinical trials, including the Phase 3 KEYNOTE-189 study (NCT04956692), wich demonstrated comparable efficacy and safety between the subcutaneous and IV formulations of pembrolizumab. Merck, the manufacturer of Keytruda, anticipates launching the subcutaneous version in the United States in October 2025, as reported by Reuters on March 27, 2025.
This approval follows a similar expansion for Keytruda in other cancer types, signaling a broader shift towards more patient-centric delivery methods for immunotherapies. The subcutaneous formulation is expected to be available in single-dose vials, streamlining the preparation and administration process. Further details regarding specific indications and dosage will be available in the prescribing information.
