On March 19, 2025, the U.S. Food and Drug Administration (FDA) granted full approval to Keytruda (pembrolizumab), a leading immunotherapy developed by Merck, for the treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1). This marks a transition from Keytruda’s earlier accelerated approval to full approval, based on data from the KEYNOTE-811 trial.
The study showed that combining Keytruda with trastuzumab and chemotherapy led to significantly better clinical outcomes than chemotherapy and trastuzumab alone. Keytruda is a PD-1 inhibitor that strengthens the body’s immune system by blocking PD-1 proteins, which cancer cells use to evade detection. By boosting the immune response, Keytruda enhances the body’s ability to fight cancer cells.
For patients with HER2-positive gastric or GEJ adenocarcinoma, this updated approval represents a significant advance, offering improved survival and disease control in a challenging cancer type. This decision reinforces the FDA’s mission to enhance access to cutting-edge treatments that deliver meaningful benefits to patients.
Disclaimer: Patients should consult their healthcare providers to determine the suitability of Keytruda for their condition.
