DCGI approves MSD India’s drug to treat triple-negative breast cancer and renal cell carcinoma

MSD (known as Merck in U.S. and Canada) recently announced that the Drug Controller General of India (DCGI) has approved KEYTRUDA (pembrolizumab), MSD’s anti-PD-1 therapy, for the treatment of triple-negative breast cancer and renal cell carcinoma in adults.

KEYTRUDA has been approved for high-risk early-stage and metastatic triple-negative breast cancer for select patients who are at a high risk of recurrence. With this approval, KEYTRUDA is now the first immunotherapy approved for the adjuvant treatment of certain patients with renal cell carcinoma and early stage triple-negative breast cancer, the company said in a statement.

Cancer cells may use the PD-1 pathway to hide from T-cells. This stops T-cells from attacking cancer cells and allows cancer cells to grow and spread. KEYTRUDA blocks the PD-1 pathway to help prevent cancer cells from hiding. KEYTRUDA helps the immune system to detect and fight cancer cells.

“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,” Rehan A. Khan, Managing Director, MSD India said in a statement.

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.