KEYTRUDA is the first immunotherapy approved in the EU for the first-line treatment of this patient population
If approved, KEYTRUDA would be the first immunotherapy for the first-line treatment of HER2-positive advanced gastric or GEJ cancer in tumors expressing PD-L1 (CPS ?1) in the EU
Based on a subgroup analysis by PD-L1 expression from KEYNOTE-811, Merck is working with the US FDA to update the current indication for KEYTRUDA in HER2-positive gastric or GEJ adenocarcinoma
Acceptance based on results from the Phase 3 KEYNOTE-859 trial, which showed significant overall survival benefit in these patients with HER2-negative disease, regardless of PD-L1 expression
Immune-mediated events and infusion reactions were higher with KEYTRUDA (38% vs 9%, respectively).
The approval is based on new data from cohorts D and K of the KEYNOTE-158 trial
New results build on previously reported significant recurrence-free survival (rfs) benefit seen in these patients
KEYTRUDA is now approved as monotherapy for adults with Renal Cell Carcinoma (RCC)
The medicine is now approved for eight indications across five different types of cancer in China.
Subscribe To Our Newsletter & Stay Updated
