Dr. Reddy’s Laboratories has announced the launch of Toripalimab in India. This drug is designed to treat adults suffering from 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 has the ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and enhance receptor internalisation (endocytosis function). This blocking of PD-1 interactions allows the immune system to attack and kill tumour cells, a significant step forward in cancer treatment.
The introduction of Toripalimab in combination with standard-of-care chemotherapy has shown a 48 per cent reduction in the risk of progression or death. This is a significant milestone for patients diagnosed with NPC in India, a country that ranks among the top five in the world in terms of disease burden.
M.V. Ramana, Chief Executive Officer, Branded Markets (India and Emerging Markets), 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. 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.”
He further added, “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.”
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.
Dr. Reddy’s Laboratories Ltd. and its subsidiaries have announced the launch of Toripalimab in India, the first and only immuno-oncology medication approved to treat nasopharyngeal cancer. Toripalimab is a new biological entity (NBE). It is the only immuno-oncology drug approved by multiple regulatory authorities worldwide, including the United States Food and Drug Administration (USFDA), the Medicines and Healthcare Products Regulatory Agency (MHRA), the European Medicines Agency (EMA), and others, for the treatment of adults with recurrent or metastatic nasopharyngeal cancer.
Dr Reddy’s already signed a license and commercialisation deal for Toripalimab with Shanghai Junshi Biosciences Co. Ltd in 2023. Dr Reddy’s got exclusive rights to develop and commercialize Toripalimab in 21 countries, including India, South Africa, Brazil, and several Latin American countries. Additionally, the arrangement authorizes Dr. Reddy’s to broaden the scope of the license to include Australia, New Zealand, and nine other nations.