DCGI approves MSD’s Keytruda for additional indications of cervical and esophageal cancers

Our Bureau, New DelhiTuesday, January 24, 2023, 18:10 Hrs  [IST]

US-based pharma major MSD (tradename of Merck & Co., Inc) announced that the Drugs Controller General of India (DCGI) has approved its anti cancer drug Keytruda (pembrolizumab), for additional indications of cervical cancer and esophageal cancer.

The company said that the anti-programmed death receptor-1 (PD-1), has received approval for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express PD-L1 with a CPS =1, and 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.

As reported earlier, the Subject Expert Committee for Oncology and Haematology which advises the drug regulator, has considered the proposal by the company and recommended grant of approval for additional indications in the second half of 2022.

The Committee noted that the post marketing data from India are consistent with the global established safety profile. It also observed that cervical cancer and esophageal cancer are serious or life-threatening diseases and the indications are already approved in countries such as the USA, European Union, Canada and Japan.


Commenting on the approval, Rehan A. Khan, managing director, MSD India said that Keytruda is bringing a clinically meaningful shift in cancer management in India and, "we are thrilled to be able to serve more patients with the new approvals for cervical and esophageal cancers".

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.

Cervical cancer is the 3rd most common cancer in India. It ranks 2nd in terms of mortality rate, with around 77,000 Indian women dying of cervical cancer every year. Despite being almost completely preventable through improved hygiene, human papillomavirus (HPV) vaccination and regular screening, cervical cancer remains the second largest women’s cancer in India.

Esophageal cancer is the 5th most common cancer in India, said the company, with approximately 63,000 cases a year. It also ranks 5th in mortality leading to around 58,000 deaths per year. Esophageal cancer has a poor prognosis despite recent advances in surgical techniques, and systemic multimodality approaches have progressed recently. Treatment options for advanced gastric esophageal cancer remain limited.

Keytruda is a therapy that works by increasing the ability of the body’s immune system to help detect and fight tumour 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 tumour cells and healthy cells.