Positive opinion granted for SC administration of KEYTRUDA for all adult indications approved in the European Union for KEYTRUDA
Merck, known as MSD outside of the United States and Canada, announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted two positive opinions for KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy. One recommends approval of a new subcutaneous (SC) route of administration and a new pharmaceutical form (solution for injection) for KEYTRUDA(pembrolizumab), which if approved would be marketed in the European Union (EU) as KEYTRUDA SC. The other positive opinion recommends approval of a new indication in locally advanced head and neck squamous cell carcinoma (LA-HNSCC). The CHMP recommendations will now be reviewed by the European Commission (EC) for marketing authorization in the EU, Iceland, Liechtenstein and Norway, and final decisions are expected in the fourth quarter of 2025.
“Building on the legacy of KEYTRUDA, we are committed to driving innovation in cancer care with new routes of administration and indications in difficult-to-treat and earlier stages of cancer,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. “This is a significant step forward in our pursuit of bringing this therapy to more patients. If approved, we believe KEYTRUDA SC has the potential to provide meaningful benefits to patients and providers in Europe because it can offer a shorter administration time compared to KEYTRUDA and the option to receive treatment in additional health care settings.”
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The first CHMP opinion recommends approval of KEYTRUDA SC as a subcutaneous, or under the skin, injection administered by a health care provider. If approved, KEYTRUDA SC could be administered in one minute every three weeks (395 mg) or in two minutes every six weeks (790 mg). As a subcutaneous injection, a health care provider would be able to administer KEYTRUDA SC in multiple settings, providing more options where patients can receive their treatment. The CHMP’s positive opinion applies to all KEYTRUDA indications for adult patients in Europe. KEYTRUDA SC contains pembrolizumab and berahyaluronidase alfa, a variant of human hyaluronidase, developed and manufactured by Alteogen Inc.
The marketing authorization application for KEYTRUDA SC is based on results from the pivotal 3475A-D77 trial comparing KEYTRUDA SC and KEYTRUDA administered every six weeks, each with chemotherapy, studied in patients with treatment naïve metastatic non-small cell lung cancer (NSCLC) with no EGFR, ALK or ROS1 genomic tumor aberrations. This trial demonstrated comparable pharmacokinetic exposure levels between KEYTRUDA SC and KEYTRUDA. The secondary efficacy endpoints of objective response rate (ORR) and progression-free survival (PFS), which were descriptive analyses, were consistent for KEYTRUDA SC with chemotherapy compared to KEYTRUDA with chemotherapy. The ORR in the KEYTRUDA SC with chemotherapy arm was 45.4% (95% CI, 39.1-51.8) and 42.1% (95% CI, 33.3-51.2) in the KEYTRUDA with chemotherapy arm.
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Results from the trial were presented at the European Lung Cancer Congress (ELCC) 2025 in March and published simultaneously in Annals of Oncology. A Biologics License Application (BLA) seeking approval of subcutaneous pembrolizumab for use in adults across all previously approved solid tumor indications for KEYTRUDA is currently under review in the U.S. with a Prescription Drug User Fee Act (PDUFA), or target action, date of Sept. 23, 2025.
The second CHMP opinion recommends approval of KEYTRUDA as monotherapy for the treatment of resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC) as neoadjuvant treatment, continued as adjuvant treatment in combination with radiation therapy with or without concomitant cisplatin and then as monotherapy in adults whose tumors express PD-L1 with a Combined Positive Score (CPS) ≥1. This treatment regimen would be the first perioperative anti-PD-1 treatment option for certain patients with resectable LA-HNSCC in the EU.
The recommendation for resectable LA-HNSCC is based on results from the pivotal Phase 3 KEYNOTE-689 trial. At the trial’s first pre-specified interim analysis, the KEYTRUDA-based perioperative regimen demonstrated a statistically significant and clinically meaningful improvement in event-free survival (EFS), the study’s primary endpoint, compared to adjuvant radiotherapy (RT) (with or without cisplatin) alone in patients with tumors expressing PD-L1 (CPS >1). Results from the trial were presented at the American Association for Cancer Research (AACR) Annual Meeting in April 2025 and also published in The New England Journal of Medicine in June 2025. In June 2025, KEYTRUDA was approved in the U.S. for the treatment of adult patients with resectable LA-HNSCC whose tumors express PD-L1 (CPS ≥1) as determined by a Food and Drug Administration (FDA)-approved test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with RT with or without cisplatin and then as a single agent.
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Source- businesswire
