Dr Reddy's launches Toripalimab to treat nasopharyngeal cancer in India

Dr. Reddy’s announced the launch of Toripalimab in India on Thursday, for patients diagnosed with nasopharyngeal carcinoma (NPC), a rare form of head and neck cancer.

Toripalimab, a New Biological Entity (NBE), is the only immuno-oncology drug approved by regulatory authorities like the USFDA, EMA, and MHRA for treating adults with recurrent or metastatic nasopharyngeal carcinoma (RM-NPC). It is globally recognised for its efficacy in this indication, the Hyderabad-based company said in a statement.

Toripalimab is an anti-PD-1 monoclonal antibody that blocks PD-1 interactions with PD-L1 and PD-L2, enhancing immune response to target and kill tumour cells through improved receptor internalisation.

In 2023, Dr. Reddy’s signed a licensing and commercialisation agreement with Shanghai Junshi Biosciences for Toripalimab. This agreement grants Dr. Reddy’s exclusive rights to develop and commercialise the drug in 21 countries, including India, South Africa, Brazil, and several Latin American nations.

MV Ramana, CEO, Branded Markets (India and Emerging Markets), Dr. Reddy’s, said, “The launch of Toripalimab is a significant milestone for patients diagnosed with nasopharyngeal carcinoma (NPC) in India.”

“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. 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.”

It also allows for the expansion of the license to cover Australia, New Zealand, and nine other countries. In India, the drug will be marketed under the brand name Zytorvi.

Before Toripalimab, chemotherapy (gemcitabine and cisplatin) was the standard treatment for RM-NPC in India. Toripalimab, combined with gemcitabine and cisplatin, is now approved as the first-line treatment for adults with metastatic or recurrent locally advanced NPC, providing a 48 per cent reduction in progression or death risk. It is also approved as monotherapy for recurrent, unresectable, or metastatic NPC after platinum chemotherapy failure.

“Our offerings aim to build an end-to-end ecosystem of care -- access to current standard of care cancer medicines across multiple countries globally, innovation in formulations, strategic collaborations for novel innovative molecules particularly in India and other emerging markets, beyond-the-pill support such as nutrition and digital tools. Our portfolio of standard of care small molecules and biosimilars across cancer types in India and other emerging markets has included Reditux, Versavo, Lenangio, and Hervycta,” Ramana added further.

NPC is a malignant tumour of the nasopharyngeal epithelium. GLOBOCAN 2022 reports over 120,000 new global cases, with 6,519 in India. The highest NPC rates in India were found in the northeastern states, particularly Kohima, Nagaland, with an incidence of 19.4/100,000 population.