Keytruda approved by EC for two new gastrointestinal cancer indications
Merck & Co – known as MSD outside the US and Canada – has announced that the European Commission (EC) has approved two new first-line indications for Keytruda (pembrolizumab) in gastrointestinal cancers.
The anti-PD-1 therapy can now be used alongside fluoropyrimidine- and platinum-containing chemotherapy to treat locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma in adults whose tumours express PD-L1, and in combination with gemcitabine and cisplatin to treat locally advanced unresectable or metastatic biliary tract carcinoma (BTC) in adults.
Approximately 1.1 million people were diagnosed with gastric cancer globally in 2020 and about 211,000 new cases of BTC are diagnosed worldwide each year.
Merck’s Keytruda works by enhancing the ability of the body’s immune system to help detect and fight tumour cells.
The EC’s decision on the drug in gastric cancer follows a recent recommendation from the European Medicines Agency’s human medicines committee and was supported by results from the phase 3 KEYNOTE-859 trial, in which the Keytruda combination reduced the risk of death by 26% in patients whose tumours expressed PD-L1.
