MSD (known as Merck in the United States and Canada) has received the Drug Controller General of India’s (DCGI) approval for Keytruda (pembrolizumab) in the treatment of triple-negative breast cancer and renal cell carcinoma in adults.
The injectable product 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, the drug becomes 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.
Immunotherapy
Keytruda is an immunotherapy that works with the immune system to help detect and fight cancer cells. It is different from chemotherapy or radiation therapy, the MSD note explained. . According to industry data, the product is priced at about ₹1,77,525 for a 4ml vial.
Rehan A. Khan, Managing Director, MSD India, said, Keytruda has become an important treatment option in India and now is approved for 14 indications across eight different types of tumours. “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,” he added.
Explaining how the product works, the company said, the immune system sends certain types of cells called T-cells throughout the body to detect and fight infections and diseases—including cancer. 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, it added.
Breast cancer
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, and is 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 o risk of recurrence. This approval will address a critical unmet need for select patients,” the company said.