India has now become the third country to have access to this PD-1 inhibitor, following the US and China. The drug will be marketed under the brand name Zytorvi.
Last year, Dr. Reddy’s agreed with Shanghai Junshi Biosciences, securing exclusive rights to develop and commercialise the therapy in 21 countries including Brazil, India and South Africa.
The agreement also allows for expansion to Australia, New Zealand, and nine other countries.
Before the introduction of Toripalimab, gemcitabine and cisplatin chemotherapy was the standard care for recurrent or metastatic RM-NPC in India.
Toripalimab, plus gemcitabine and cisplatin, has shown a 48% decrease in the progression or death risk. It is also approved as monotherapy for adult individuals with NPC who have disease progression following a platinum-containing chemotherapy.
A New Biological Entity (NBE), the drug has been approved by various health regulators including the US Food and Drug Administration (FDA), the Medicines and Healthcare products Regulatory Agency (MHRA), and the European Medicines Agency (EMA), among others.
A malignant tumour of the nasopharyngeal epithelium, NPC has seen over 120,000 new cases worldwide in 2022.
The therapy’s mechanism involves blocking PD-1 interactions with its ligands, thereby enhancing the immune system’s ability to eliminate tumour cells.
Dr. Reddy’s Branded Markets (India and Emerging Markets) CEO M.V. Ramana said: “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.
“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. “