Dr. Reddy’s Laboratories has received approval from the Central Drugs Standard Control Organisation (CDSCO), under the Drugs Controller General of India (DCGI) for Zytorvi® (toripalimab), in combination with cisplatin and paclitaxel, for the first-line treatment of adults with unresectable advanced, recurrent or metastatic esophagealsquamous cell carcinoma (ESCC). 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.
Dr. Reddy’s entered into a licensing and commercialization agreement with Junshi Biosciences in 2023 for toripalimabacross 21 countries. Globally, Toripalimab is approved by regulatory authorities including the U.S. Food and Drug Administration (USFDA), the European Medicines Agency (EMA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). Notably, the EMA approval is for first-line treatment of ESCC irrespective of PD-L1 expression. The approval expands Zytorvi’s approved indications in India, offering an additional immunotherapy-based treatment option for eligible patients with advanced esophageal cancer.
Toripalimab is a monoclonal antibody that targets programmed cell death protein 1 (PD-1), an immune checkpoint receptor. By blocking this pathway, the therapy helps the immune system recognise and attack cancer cells. Its combination with chemotherapy aims to improve treatment outcomes in patients with advanced ESCC.
The approval is supported by findings from the Phase III JUPITER-06 clinical trial, which evaluated toripalimabalongside chemotherapy against chemotherapy alone. Reported results showed a median overall survival of 17.7 months with toripalimab plus chemotherapy, compared with 12.9 months with chemotherapy alone. The combination also demonstrated a reported 42% reduction in the risk of disease progression or death.
The development marks the second approved indication for Zytorvi® in India, following its approval for recurrent or metastatic nasopharyngeal carcinoma.
The latest approval strengthens Dr. Reddy’s oncology portfolio and highlights the growing role of immunotherapy-based combinations in the treatment of advanced cancers.
Written by: Pramit Hazra
Graphics by: Pramit Hazra
