Dr Reddy's Laboratories announced on Wednesday that it has received approval from the Drugs Controller General of India (DCGI) for the drug Zytorvi (toripalimab). This will expand access to first-line immunotherapy for patients with esophageal squamous cell carcinoma (ESCC) in India.
The pharmaceutical company specified that the drug is approved for combination first-line treatment in adult patients with unresectable advanced, recurrent, or metastatic ESCC, in combination with cisplatin and paclitaxel.
This approval is the second indication for Zytorvi in the country, as it was previously used to treat nasopharyngeal cancer. The company noted that ESCC accounts for about 80 percent of all cases of esophageal cancer in India.
Zytorvi contains toripalimab, which is a monoclonal antibody. It binds to PD-1 and blocks its interaction with PD-L1 and PD-L2, thereby stimulating T-cell activity against cancer cells.
The approval is based on the results of the Phase 3 JUPITER-06 study. According to the press release, the combination of toripalimab with paclitaxel and cisplatin reduced the risk of disease or death by 42 percent compared to chemotherapy administered alone.
Furthermore, it was added that the median overall survival was 17.7 months when using toripalimab plus chemotherapy, compared to 12.9 months when using chemotherapy alone.
Dr Reddy's holds the rights to commercialize toripalimab in 21 countries according to an agreement concluded with Junshi Biosciences in 2023.
