DCGI approves MSD India's drug KEYTRUDA for breast cancer in adult patients

MSD India (Merck) on Wednesday announced that the Drug Controller General of India (DCGI) has approved KEYTRUDA (pembrolizumab). This MSD's anti-PD-1 therapy has been given the green light for the treatment of triple-negative breast cancer (TNBC) and renal cell carcinoma (RCC) in adult patients. KEYTRUDA is now approved for 14 indications across eight tumour types in India.

Unlike traditional chemotherapy or radiation therapy, KEYTRUDA enhances the body's own immune system to combat cancer cells. This drug targets the PD-1 pathway, which cancer cells often exploit to evade detection and attack by the body's T-cells. KEYTRUDA, an anti-programmed death receptor-1 (PD-1) therapy, enhances the immune system's ability to identify and combat tumour cells. It does so by blocking the interaction between PD-1 and its ligands, PD-L1 and PD-L2. This action activates T lymphocytes, which can impact both tumour cells and healthy cells.

Commenting on the approval, Rehan A. Khan, managing director, MSD India said, "With these approvals, KEYTRUDA has become an important treatment option in India and now is approved for 14 indications across eight different types of tumours." He further added, "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."

The drug has been approved for high-risk early-stage and metastatic TNBC in select patients who face a high risk of recurrence. TNBC is known to be one of the most aggressive forms of breast cancer, with a higher risk of recurrence within the first five years after diagnosis.

Renal cell carcinoma (RCC), the most common type of kidney cancer, predominantly affects men and has limited treatment options, often leaving patients at risk of recurrence.