India
Dr. Reddy launches world’s first immuno-onco drug for nasopharyngeal cancer in India | India News – Times of India
This makes India the third largest country in the world, after China and the United States United States to access this next generation PD-1 (programmed cell death protein 1) inhibitor monoclonal antibody created by Dr. Reddy’s will be marketed under the brand name Zytorvi in India.
Toripalimab is a novel 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 tumor cells.
It is the only immuno-oncology drug approved by several regulatory authorities worldwide, such as the United States Food and Drug Administration (USFDA), the European Medicines Agency (EMA), the Medicines and Healthcare products Regulatory Agency (MHRA), among others, for the treatment of adults with recurrent or metastatic nasopharyngeal cancer (RM-NPC).
The monoclonal antibody was launched a year after Dr. Reddy’s had entered into a licensing and commercialization agreement Shanghai Junshi Biosciences Co Ltd that gave it exclusive rights to develop and commercialize Toripalimab in 21 countries, including India, South Africa, Brazil and countries in Latin America. The agreement allows Dr. Reddy’s also expanding the scope of the license to Australia, New Zealand and nine other countries.
The company pointed out that before toripalimab, the standard treatment 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. with the risk of progression or death.
Toripalimab is also approved as monotherapy for the treatment of adults with relapsed, unresectable, or metastatic NPC with disease progression during or after platinum-containing chemotherapy.
The CEO of Dr. Terming the launch of toripalimab as an important milestone for patients suffering from NPC in India, Reddy for Branded Markets (India and Emerging Markets) said: “India is among the top five countries in the world in terms of disease burden. of NPC, a rare form of head and neck cancer with a poor prognosis for patients in advanced stages. As the next generation PD-1 inhibitor, toripalimab has demonstrated superior outcomes for RM-NPC compared to standard of care, addressing a significant unmet need for patients with NPC in India.”