Indian pharmaceutical company Dr. Reddy’s Laboratories has announced the India launch of Toripalimab, an immunooncology drug approved for the treatment of nasopharyngeal cancer.
Toripalimab is an anti-PD-1 monoclonal antibody designed to block PD-1 interactions with its ligands, PD-L1 and PD-L2. This action enhances receptor internalisation, boosting the immune system’s ability to target and destroy tumour cells.
Toripalimab is a new biological entity (NBE) and the only immuno-oncology therapy approved globally for treating recurrent or metastatic nasopharyngeal carcinoma (RM-NPC).
It has been already approved by regulatory authorities like the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Medicines and Healthcare products Regulatory Agency (MHRA).
In September, Junshi Biosciences and its wholly owned subsidiary, TopAlliance Biosciences secured European Commission (EC) approval for toripalimab to treat nasopharyngeal carcinoma (NPC) and oesophageal squamous cell carcinoma.
In 2023, Dr. Reddy’s signed a licensing and commercialisation deal with Shanghai Junshi Biosciences for Toripalimab.
This agreement grants the Indian drugmaker exclusive rights to develop and commercialise the drug in 21 countries, including India, South Africa, Brazil, and Latin America.
The deal also enabled Dr. Reddy’s to expand the licence to include Australia, New Zealand, and nine additional countries.
India is the third country, after China and the US, to receive this next-generation PD-1 inhibitor. The pharmaceutical firm will market it as Zytorvi in India.
Dr. Reddy’s branded markets (India and emerging markets) CEO MVRamana said: “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.”
According to Dr. Reddy’s, the existing treatment for RM-NPC in India was chemotherapy with gemcitabine and cisplatin.
Toripalimab is now approved as a first-line treatment for adults with metastatic or recurrent locally advanced NPC, in combination with gemcitabine and cisplatin.
This combination has demonstrated a 48% reduction in the risk of progression or death.
Additionally, the PD-1 inhibitor is approved as a monotherapy for adults with recurrent unresectable or metastatic NPC whose disease has progressed after platinum-based chemotherapy.
This launch follows the recent introduction of Ivermectin Tablets USP (3 mg) in the US market by Dr. Reddy’s and Senores Pharmaceuticals.
