DCGI approves MSD’s drug Keytruda for the treatment of triple negative breast cancer and renal cell carcinoma

MSD (known as Merck in the US and Canada) recently announced that the Drugs Controller General of India (DCGI) has approved Keytruda (pembrolizumab), MSD’s anti-PD-1 therapy, for the treatment of triple-negative breast cancer (TNBC) and renal cell carcinoma (RCC) 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.

Keytruda is an immunotherapy that works with the immune system to help fight cancer cells. It is different from chemotherapy or radiation therapy. The immune system sends certain types of cells called T-cells throughout your 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. Keytruda helps the immune system to detect and fight cancer cells.

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.”

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.

RCC is by far the most common type of kidney cancer. RCC is about twice as common in men than in women. Despite decades of research, limited treatment options are available for treatment of RCC which is 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 tumour cells and healthy cells.

For 130 years, MSD, known as Merck in the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Today, MSD continues to be at the forefront of research to prevent and treat diseases including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!