Dr. Reddy's Laboratories has launched Toripalimab in India, marking a significant advancement in the treatment of nasopharyngeal carcinoma (NPC). This immuno-oncology drug, a New Biological Entity (NBE), is now available to Indian patients under the brand name Zytorvi.
With this launch, India becomes the third country after China and the United States to gain access to this next-generation PD-1 inhibitor. The introduction of Toripalimab offers a new treatment option for patients with recurrent or metastatic nasopharyngeal carcinoma (RM-NPC), a rare and aggressive cancer of the head and neck.
Clinical Efficacy and Approvals
Toripalimab has received approval from several regulatory authorities worldwide, including the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Medicines and Healthcare products Regulatory Agency (MHRA). These approvals are based on clinical trials demonstrating the drug's efficacy in treating RM-NPC.
Clinical data indicates that Toripalimab, when used in combination with gemcitabine and cisplatin chemotherapy, shows a 48% reduction in the risk of disease progression or death. The drug is also approved as a monotherapy for adults with NPC who have experienced disease progression following platinum-based chemotherapy.
Mechanism of Action
Toripalimab is an anti-PD-1 monoclonal antibody. It functions by blocking the interaction between PD-1 and its ligands, PD-L1 and PD-L2. This blockade enhances the immune system's ability to recognize and destroy tumor cells. By promoting the immune system’s attack on tumor cells, toripalimab offers a targeted approach to cancer treatment.
Impact on Treatment Landscape
Prior to the availability of Toripalimab, the standard of care for RM-NPC in India was chemotherapy with gemcitabine and cisplatin. The introduction of Toripalimab provides a new first-line treatment option that has demonstrated superior outcomes compared to chemotherapy alone.
M.V. Ramana, CEO of Branded Markets (India and Emerging Markets) at Dr. Reddy’s, stated, "The launch of Toripalimab is a significant milestone for patients diagnosed with nasopharyngeal carcinoma (NPC) in India. NPC is a rare form of head and neck cancer... As the next generation PD-1 inhibitor, Toripalimab has demonstrated superior outcomes for RM-NPC versus standard of care, thereby meeting a significant unmet need for patients with NPC in India."
Disease Burden and Availability
Nasopharyngeal carcinoma is a relatively rare cancer, but India is among the top five countries in the world in terms of disease burden. According to GLOBOCAN 2022 statistics, there were 6,519 newly diagnosed cases of NPC in India. The highest age-adjusted rates for NPC were found in the north-eastern states of India, with Kohima in Nagaland reporting an incidence of 19.4/100,000 population.
Dr. Reddy's launch of Toripalimab in India marks a significant step forward in addressing the unmet medical needs of patients with nasopharyngeal carcinoma, offering a new and effective treatment option for this challenging disease.
