Dr. Reddy's launches Toripalimab in India to treat rare form of head & neck cancer

Dr. Reddy’s Laboratories on Thursday announced the launch of Toripalimab in India to treat adults with Nasopharyngeal carcinoma (NPC) -- a rare and aggressive form of head and neck cancer that originates in the nasopharynx, the upper part of the throat.

Toripalimab is an anti-PD-1 monoclonal antibody that can block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalisation (endocytosis function). When PD-1 interactions are blocked, the immune system gets the ability to attack and kill tumour cells.

A combination of Toripalimab and standard-of-care chemotherapy has shown a 48 per cent reduction in the risk of progression or death.

“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. However, the prognosis of the disease for patients in advanced stages is poor, and India is among the top five countries in the world in terms of disease burden,” said M.V. Ramana, Chief Executive Officer, Branded Markets (India and Emerging Markets), Dr. Reddy’s.

“As the next generation PD-1 inhibitor, Toripalimab has demonstrated superior outcomes for recurrent or metastatic nasopharyngeal carcinoma (RM-NPC) versus standard of care, thereby meeting a significant unmet need for patients with NPC in India,” he added.

The Central Drugs Standard Control Organisation (CDSCO) had, in April, approved Dr. Reddy's lab to import and market toripalimab. The drug will be marketed in India under the brand name Zytorvi.

Previously, the standard of care for RM-NPC in India was chemotherapy (gemcitabine and cisplatin). Toripalimab is indicated as the first-line treatment of adults with metastatic or recurrent locally advanced NPC in combination with gemcitabine and cisplatin.

NPC is a malignant tumour that arises from the epithelium of the nasopharynx. According to GLOBOCAN 2022 statistics, the number of newly diagnosed NPC cases in 2022 exceeded 120,000 worldwide. In India, there were 6,519 newly diagnosed cases of NPC in 2022, with Kohima in Nagaland having an incidence of 19.4/100,000 population.

Toripalimab is the only immuno-oncology drug approved by the US Food and Drug Administration (USFDA), European Medicines Agency (EMA), Medicines and Healthcare Products Regulatory Agency (MHRA), and others for the treatment of adults with RM-NPC.