DCGI approves MSD India’s Keytruda for treating cervical and esophageal cancers

The Drugs Controller General of India (DCGI) has approved MSD’s Keytruda (pembrolizumab), anti-PD-1 therapy for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express PD-L1 with a CPS≥1, according to a statement from MSD.

In addition, Keytruda has also been approved for the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the esophagus or HER-2 negative gastroesophageal junction adenocarcinoma, in adults whose tumours express PD-L1 with a CPS ≥ 10. The approval was based on the phase-III Keynote 590 and 826 studies for esophageal and cervical cancer, respectively, the statement said.

It further mentioned that Keytruda is the first cancer immunotherapy to be approved in India for the treatment of cervical cancer and the first immunotherapy to be approved as a first-line treatment for a significant sub-group of patients, who otherwise only had the option of chemotherapy as their treatment for esophageal cancer.