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Approval Granted by DCGI for KEYTRUDA in Treating Triple Negative Breast Cancer and Renal Cell Carcinoma

NextEdge Admin

12 Nov 2023

2 min 21 sec

Merck, known as MSD in the US and Canada, has received approval from the Drug Controller General of India (DCGI) for its groundbreaking immunotherapy drug, KEYTRUDA (pembrolizumab). This approval marks a significant milestone in the treatment of triple-negative breast cancer and renal cell carcinoma in adults. KEYTRUDA has been authorized for both high-risk early-stage and metastatic triple-negative breast cancer, specifically for patients at a high risk of recurrence.

Notably, this achievement positions KEYTRUDA as the first immunotherapy to gain approval for adjuvant treatment in certain renal cell carcinoma patients and early-stage triple-negative breast cancer. Thisimmunotherapy operates uniquely by engaging the patient’s immune system to combat cancer cells, distinct from traditional chemotherapy or radiation therapy.

KEYTRUDA’s mechanism involves inhibiting the PD-1 pathway that cancer cells exploit to evade detection and attack by the body’s T-cells. By blocking this pathway, KEYTRUDA empowers the immune system to recognize and confront cancer cells effectively. Triple-negative breast cancer, recognized as the most aggressive form, poses a high risk of recurrence within the initial five years after diagnosis and often yields poorer outcomes compared to other breast cancer subtypes.

Renal cell carcinoma, the most prevalent type of kidney cancer, disproportionately affects men and has limited treatment options available, putting patients at a heightened risk of recurrence. The approval of KEYTRUDA addresses a critical unmet need for specific patients, offering new hope and improved outcomes in the battle against these formidable diseases.