> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Merck Seeks Approval for Subcutaneous Keytruda
- URL: https://www.fdaweb.com/merck-seeks-approval-for-subcutaneous-keytruda/
- Published: 2025-03-27T12:00:00.000Z
- Updated: 2026-09-14T14:56:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158908

FDA has accepted for review a Merck BLA for a subcutaneous formulation of Keytruda (pembrolizumab) for its use across all previously approved solid tumor indications. The agency has set a user fee review action target date of 9/23.

The submission is based on data from Merck’s pivotal 3475A-D77 Phase 3 trial, evaluating the subcutaneous administration of pembrolizumab together with berahyaluronidase alfa (MK-3475A). “The study met its primary endpoints, demonstrating noninferior pharmacokinetics (PK) for subcutaneous pembrolizumab administered with chemotherapy with a median injection time of two minutes, versus intravenous (IV) Keytruda (pembrolizumab) administered with chemotherapy for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC),” the company says.

“These study findings demonstrate subcutaneous pembrolizumab reduces time demands for both the patient and the healthcare provider, all while providing a consistent efficacy and safety profile with IV pembrolizumab,” a Merck release says.