HYDERABAD: Pharma major Dr Reddy’s Laboratories Ltd on Thursday said it has rolled out Toripalimabthe world’s first and only immuno-oncology drug approved for the treatment of nasopharyngeal carcinoma, which is a rare form of head and neck cancer, in the Indian market.
With this, India becomes the third country in the world after China and the United States to get access to this next generation PD-1 (programmed cell death protein 1) inhibitor monoclonal antibody that will be marketed by Dr Reddy’s under the brand name Zytorvi in India.
Toripalimab is a new biological entity (NBE) that has the ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2 and promotes the immune system’s ability to attack and kill tumour cells.
It is the only immuno-oncology drug approved by various regulatory authorities globally such as the United States Food and Drug Administration (USFDA), European Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA), among others, for the treatment of adults with recurrent or metastatic nasopharyngeal carcinoma (RM-NPC).
The monoclonal antibody has been launched a year after Dr Reddy’s entered into a license and commercialisation agreement with Shanghai Junshi Biosciences Co Ltd that gave it exclusive rights to develop and commercialise Toripalimab in 21 countries including India, South Africa, Brazil and countries in Latin America. The agreement also allows Dr Reddy’s to expand the scope of the license to cover Australia, New Zealand and nine other countries.
The company pointed out that prior to Toripalimab, the standard of care for RM-NPC in India was chemotherapy (gemcitabine and cisplatin) but Toripalimab is now indicated as a first-line treatment in combination with gemcitabine and cisplatin and has shown a 48% reduction in risk of progression or death.
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.
Terming the launch of Toripalimab as a significant milestone for patients suffering from NPC in India, Dr Reddy’s CEO for branded markets (India and emerging markets), MV Ramana said: “India is among the top five countries in the world in terms of disease burden of NPC, which is a rare form of head and neck cancer with poor prognosis for patients in advanced stages. 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.”
