Mumbai (Maharashtra) [India], January 24 (ANI): 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, said pharma major MSD.
In addition, Keytruda has also been approved for the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the oesophagus or HER-2 negative gastroesophageal junction adenocarcinoma, in adults whose tumours express PD-L1 witha CPS >= 10.
The company further said the approval was based on the Phase 3 Keynote 590 and 826 studies for oesophagal and cervical cancer respectively.
Commenting on the approval, Rehan A Khan, managing director, MSD India Region said, "At MSD, we are committed to creating access to high-quality medicines that can significantly improve health outcomes. 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."According to MSD, 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 oesophagal cancer. (ANI)