Blockbuster Immuno-oncology Drugs Set to Hit the Indian Market


After an extraordinary success rate in treatment and progression free survival of cancer patients across the globe, best in class immune-oncology drugs, US-based Merck’s Keytruda and Bristol-Myers Squibb’s (BMS) Opdivo are set to launch in the Indian market sometime around the end of the year.

merck logoKeytruda recently received approval from Drug Controller General of India and also recommended by expert oncologists and a powerful apex committee. Simultaneously, BMS Opdivo already obtained clinical trial waiver few months back and made its way to be launched in the market along with Keytruda. In November 2015, a Subject Export Committee (SEC) in India granted import and marketing for Keytruda.

pd-1-pdl1 protein-protein interaction

Figure 1. PD-L1 interference affects B7.1 and PD-1 binding (photo credit: F. Hoffmann-La Roche Ltd).

Keytruda and Opdivo are humanized anti-PD-1 monoclonal antibody used for the treatment of various types of cancers. While Keytruda is approved by U.S. Food and Drug Administration (FDA) for the treatment of advanced melanoma and metastatic non-small cell lung cancer (NSCLC), Opdivo is approved for the treatment of wide range of cancers such as melanoma, metastatic NSCLC, renal cell carcinoma, and Hodgkin’s lymphoma. However, Merck’s Keytruda is also being tested as a prospective therapy for many types of cancers such as triple-negative breast cancer, urothelial cancer, gastric cancer, and head and neck cancer.

The drugs Keytruda (pembrolizumab) and Opdivo (nivolumab) works as checkpoint inhibitor by blocking the negative signal and inhibiting the interaction between programmed death ligand 1 (PD-L1) on tumor cells and PD-1 on T-Lymphocytes, that provide negative signal to the immune system to not attack the tumor cells. Thus, both the drugs bind to the  PD-1 receptor and rejuvenate the immune system to target and destroy cancer cells .

The drugs were observed to be highly target specific and significantly increased the longevity of the patients, according to the recent follow-up studies conducted of the patients receiving Keytruda and Opdivo. But the major obstacle of the drug is its high cost. The drug presently has a list price of about $150,000 a year globally. Even though the drugs launched in the Indian market will be available at a relatively low cost in comparison to global rate, but still it will be too expensive to be afforded by general public.

During the year 2015, the global sales generated by Keytruda was $566 million while Opdivo generated approximately $942 million and gained the status of blockbuster drug. These two drugs are single-handedly responsible for changing and shaping the healthcare segment of cancer treatments and now even India will be benefited by these innovative and effective immune-oncology drugs.

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