Dr. Reddy’s launches Toripalimab under the brand name Zytorvi in India

Dr. Reddy’s Laboratories announced the launch of Toripalimab, immuno-oncology drug in India. Toripalimab is a New Biological Entity (NBE). It is approved by various regulatory authorities around the world such as the United States Food and Drug Administration (USFDA), European Medicines Agency (EMA), Medicines and Healthcare Products Regulatory Agency (MHRA), and others for the treatment of adults with recurrent or metastatic nasopharyngeal carcinoma (RM-NPC).

In 2023, Dr. Reddy’s entered into a license and commercialisation agreement with Shanghai Junshi Biosciences for Toripalimab. Under this agreement, Dr. Reddy’s obtained exclusive rights to develop and commercialise Toripalimab in 21 countries including India, South Africa, Brazil and various countries in Latin America. Additionally, the agreement allows Dr. Reddy’s to expand the scope of the license to cover Australia, New Zealand and nine other countries. With this launch by Dr. Reddy’s, India becomes the third country in the world after China and the United States to receive access to this next-generation PD-1 inhibitor (1). Dr. Reddy’s will market it under the brand name Zytorvi in India.

The standard of care for RM-NPC in India before Toripalimab was chemotherapy (gemcitabine and cisplatin). Toripalimab is indicated as first-line treatment of adults with metastatic or recurrent locally advanced NPC in combination with gemcitabine and cisplatin. This combination has shown a 48 per cent reduction in risk of progression or death (2). Additionally, Toripalimab has also been approved as monotherapy for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after platinum-containing chemotherapy.

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 (3). The highest age-adjusted rates for NPC were found in the northeastern states in India, with Kohima in Nagaland having an incidence of 19.4/100,000 population (4).

Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalisation (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune system’s ability to attack and kill tumour cells (5). 

References 

1. Ravindranathan S, Wang X, et al. Characteristics of toripalimab: a next generation anti-PD-1 antibody with potent T cell activation and enhanced clinical efficacy irrespective of PD-L-1 status. J Immunother Cancer 2023;11(Suppl 1):A1–A1731
2. Mai, HQ., Chen, QY., Chen, D. et al. Toripalimab or placebo plus chemotherapy as first-line treatment in advanced nasopharyngeal carcinoma: a multicenter randomized phase 3 trial. Nat Med 27, 1536–1543 (2021).
3.  Ferlay J, Ervik M, Lam F, Laversanne M, Colombet M, Mery L, Piñeros M, Znaor A, Soerjomataram I, Bray F (2024). Global Cancer Observatory: Cancer Today. Lyon, France: International Agency for Research on Cancer. Available from: https://gco.iarc.who.int/today. 
4. Mailankody, Sharada, et al. “Epidemiology of rare cancers in India and South Asian countries–remembering the forgotten.” The Lancet Regional Health-Southeast Asia 12 (2023). 
5. Chen YP, Chan AT, Le QT, Blanchard P, Sun Y, Ma J. Nasopharyngeal carcinoma. The Lancet. 2019 Jul 6;394(10192):64-80.