New Delhi: Dr Reddy's Laboratories on Wednesday said it has received approval from the Drugs Controller General of India (DCGI) for Zytorvi (toripalimab), through which it aims to expand access to first-line immunotherapy for patients with advanced esophageal squamous cell carcinoma (ESCC) in India.
The drug has been approved in combination with cisplatin and paclitaxel for the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic ESCC, the pharma company said in a release.
This marks Zytorvi's second approved indication in the country, expanding beyond nasopharyngeal carcinoma.
ESCC accounts for approximately 80 per cent of all esophageal cancer cases in India, the company said.
Zytorvi contains toripalimab, a monoclonal antibody that binds to PD-1 and blocks its interaction with PD-L1 and PD-L2, thereby supporting T-cell activity against cancer cells.
The approval is supported by results from the Phase 3 JUPITER-06 trial. In the study, toripalimab in combination with paclitaxel and cisplatin reduced the risk of disease or death by 42 per cent compared with chemotherapy alone, according to the release.
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At the final overall-survival analysis, median overall survival was 17.7 months with toripalimab plus chemotherapy compared with 12.9 months with chemotherapy alone, it added.
Dr. Reddy's holds commercialisation rights for toripalimab across 21 countries under a 2023 agreement with Junshi Biosciences.