Toripalimab, a new biological entity (NBE), is approved by various regulatory authorities around the world including the US Food and Drug Administration, European Medicines Agency and Medicines and Healthcare products Regulatory Agency for the treatment of adults with recurrent or metastatic nasopharyngeal carcinoma (RM-NPC).
Last year, Dr Reddy’s entered into a licence and commercialisation agreement with Shanghai Junshi Biosciences Co. for toripalimab. Under this agreement, it obtained exclusive rights to develop and commercialise the drug in 21 countries including India, South Africa, Brazil and various countries in South America. The agreement also allows Dr Reddy’s to expand the scope of the licence to cover Australia, New Zealand and nine other countries.
With this launch, India has become the third country, after China and the United States, to receive access to this next generation PD-1 inhibitor. 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.
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