Dr Reddy’s Laboratories has received approval from the Drugs Controller General of India (DCGI) for its immunotherapy drug Zytorvi (toripalimab) for the first-line treatment of adults with advanced oesophageal squamous cell carcinoma (ESCC). The approval allows the drug to be used in combination with the chemotherapy medicines cisplatin and paclitaxel in patients with unresectable advanced, recurrent or metastatic disease.
The approval marks Zytorvi’s second approved indication in India. The drug was launched in the country in November 2024 for recurrent or metastatic nasopharyngeal carcinoma. The latest decision expands its use to another cancer type and adds an immunotherapy-based option for eligible patients with advanced oesophageal cancer.
Clinical Trial Results Support Approval
The approval is supported by findings from the Phase III JUPITER-06 clinical trial. According to the reported results, toripalimab combined with cisplatin and paclitaxel reduced the risk of disease progression or death by 42% compared with chemotherapy alone.
At the final overall-survival analysis, median overall survival was 17.7 months for patients receiving the combination treatment, compared with 12.9 months for those receiving chemotherapy alone. Clinical benefits were observed across groups with different levels of PD-L1 expression, a biomarker used in cancer treatment decisions.
The approved indication in India does not require patient selection based on PD-L1 expression. This allows eligible patients to be considered for the treatment regardless of their biomarker status, subject to clinical assessment.
How Zytorvi Works
Zytorvi contains toripalimab, a humanised monoclonal antibody that targets the programmed death receptor-1 (PD-1). By blocking the interaction between PD-1 and its ligands, PD-L1 and PD-L2, the drug helps support the immune system’s T-cell response against cancer cells.
Oesophageal squamous cell carcinoma develops in the squamous cells lining the oesophagus, the muscular tube that carries food and liquids from the throat to the stomach. ESCC accounts for approximately 80% of oesophageal cancer cases in India, according to the company.
Dr Reddy’s Expands Oncology Portfolio
Dr Reddy’s entered into a licensing and commercialisation agreement with Shanghai Junshi Biosciences in 2023, securing rights to develop and commercialise toripalimab in 21 countries, including India. The drug has also received approvals from regulators in markets including the United States, the European Union and the United Kingdom.
The new indication strengthens Dr Reddy’s oncology portfolio and expands the potential use of immunotherapy in advanced cancer care. The treatment is intended for eligible patients under medical supervision, with decisions based on individual clinical circumstances.
