MSD (tradename of Merck & Co.) has announced that the Drugs Controller General of India (DCGI) has approved Keytruda (pembrolizumab), MSD’s 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.

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 tumors express PD-L1 with a CPS ≥ 10. The approval was based on the Phase 3 Keynote 590 and 826 studies for esophageal and cervical cancer respectively.

Commenting on the approval, Rehan A. Khan, Managing Director, MSD India Region said “Timely access to new and innovative treatment strategies for cancer patients is essential in improving the quality of care, and alleviating the burden of cancer on the economy, society and the wider community in India.”

Keytruda is bringing a clinically meaningful shift in cancer management in India. It 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.

Keytruda is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. It is a humanised monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.