Dr. Reddy’s receives DCGI approval for Zytorvi to treat esophageal cancer

Dr. Reddy’s Laboratories Ltd. has received approval from India’s Central Drugs Standard Control Organisation (CDSCO) for Zytorvi (toripalimab). The drug is authorized for the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC).

Zytorvi will be used in combination with cisplatin and paclitaxel. Notably, the approval does not require patient selection based on PD-L1 expression, meaning the treatment is applicable regardless of biomarker status. This decision follows results from the Phase 3 JUPITER-06 trial, which showed that the combination therapy reduced the risk of disease progression or death by 42% compared to chemotherapy alone. Median overall survival was 17.7 months for the combination group versus 12.9 months for chemotherapy alone.

Dr. Reddy’s secured the rights to develop and commercialize toripalimab in 21 countries, including India, through a 2023 licensing agreement with Junshi Biosciences. The approval addresses a significant health need in India, where esophageal cancer was the fourth leading cause of cancer-related deaths in 2024.