【FDA Approval Alert】Merck’s pembrolizumab (Keytruda) Approved for HER2-Positive PD-L1 CPS ≥1 Gastric and GEJ Adenocarcinoma (March 19, 2025)
On March 19, 2025, the U.S. FDA granted regular approval to pembrolizumab (Keytruda) in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma expressing PD-L1 (CPS ≥1). This converts the prior accelerated approval granted in May 2021 to full approval. Approval was based on KEYNOTE-811 (NCT03615326).
Disease Overview: HER2-Positive Gastric and GEJ Adenocarcinoma
HER2-positive gastric/GEJ adenocarcinoma is a molecular subtype increasingly treated with combined targeted and immunotherapy. PD-L1 expression enhances response to immune checkpoint inhibitors.
Treatment Summary
- Drug Name: pembrolizumab (Keytruda)
- Company: Merck & Co., Inc.
- Approval Date: March 19, 2025
- Indication: First-line treatment of HER2-positive PD-L1 CPS ≥1 advanced gastric/GEJ adenocarcinoma
- Mechanism of Action: Anti-PD-1 antibody (immune checkpoint inhibitor)
- Pivotal Trial: KEYNOTE-811 (NCT03615326)
- Key Efficacy:
- Median PFS: 10.9 vs 7.3 months (HR 0.72; 95% CI: 0.60–0.87)
- Median OS: 20.1 vs 15.7 months (HR 0.79; 95% CI: 0.66–0.95)
- ORR: 73% vs 58%, Median DOR: 11.3 vs 9.6 months
Patient-Friendly Summary
Keytruda, combined with chemotherapy and trastuzumab, enhances immune response to improve outcomes in advanced HER2-positive, PD-L1-positive gastric/GEJ cancer.
M&A Information
- Subsidiary: Not applicable (Merck in-house development)
- Acquisition Date: Not applicable
- Development Stage at Acquisition: Not applicable
- Investor Information: Public Investors (NYSE: MRK)
Source
This approval information is based on data from Drugs@FDA (U.S. FDA) and AACR releases.
