New EC approvals for Keytruda in gastrointestinal cancer

18 December 2023

The European Commission (EC) has approved two new indications for Keytruda (pembrolizumab), the mega blockbuster anti-PD-1 therapy developed and marketed by US pharma giant Merck & Co (NYSE: MRK), to now include additional indications in gastrointestinal cancers:

Keytruda in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma in adults whose tumors express PD-L1 with a Combined Positive Score (CPS) ≥1; and
Keytruda in combination with gemcitabine and cisplatin for the first-line treatment of locally advanced unresectable or metastatic biliary tract carcinoma (BTC) in adults.

These approvals by the EC follow positive recommendations from the Committee for Medicinal Products for Human Use received in October and November this year, and were based on overall survival (OS) results from the Phase III KEYNOTE-859 and KEYNOTE-966 trials, respectively.

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