Dr. Reddy’s Laboratories has received approval from the Drug Controller General of India (DGCI) for Zytorvi, to expand the use in combination with cisplatin and paclitaxel for the first-line immunotherapy for patients with advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC).
Dr. Reddy’s entered into a licensing and commercialization agreement with Junshi Biosciences in 2023 for toripalimab across 21 countries. Globally, Toripalimab is approved by regulatory authorities including the USFDA, the European Medicines Agency (EMA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
In 2024, esophageal cancer was the fourth leading cause of cancer-related death in India, accounting for approximately 8.1% of all cancer deaths. ESCC, the predominant subtype, accounts for approximately 80% of all esophageal cancer cases in India. Through Zytorvi, Dr. Reddy’s aims to expand access to first-line immunotherapy for appropriate patients with advanced ESCC in India.
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.
As per a company press release, the approval is supported by the 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% compared with chemotherapy alone.