MSD wins DCGI nod for Keytruda for treatment of triple negative breast cancer, renal cell carcinoma

Commenting on the approval, Rehan A. Khan, Managing Director, MSD India said, “At MSD, we are committed to improving access to high-quality medicines that significantly improve health outcomes. With these approvals, KEYTRUDA has become an important treatment option in India and now is approved for 14 indications across 8 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.”

Triple-negative breast cancer (TNBC) is the most aggressive type of breast cancer, which has the highest risk of recurrence within the first five years after diagnosis and is associated with worse outcomes compared to other forms of breast cancer.

Renal cell carcinoma is by far the most common type of kidney cancer. Renal cell carcinoma is about twice as common in men than in women. Despite decades of research, limited treatment options are available for treatment of renal cell carcinoma who are often at risk of recurrence. This approval will address a critical unmet need for select patients.

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. KEYTRUDA is a humanized 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.