DCGI Approves Zytorvi for Advanced Esophageal Cancer

On 21 October 2026, the Drugs Controller General of India (DCGI) approved Zytorvi (toripalimab) with cisplatin and paclitaxel as first-line treatment for adults with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC). The approval is Zytorvi’s second indication in India, after its approval for nasopharyngeal carcinoma.

Esophageal Squamous Cell Carcinoma

The oesophagus is a muscular tube that carries food from the throat to the stomach. ESCC is a cancer arising from the squamous cells lining the oesophagus; it accounts for about 80% of esophageal cancer cases in India. “Unresectable” describes a tumour that cannot be removed through surgery, while “metastatic” refers to cancer that has spread to distant parts of the body. First-line treatment is the initial treatment used for a disease.

Toripalimab and Combination Treatment

Toripalimab is a monoclonal antibody that targets programmed cell death protein 1 (PD-1), an immune checkpoint receptor. PD-1 inhibitors block a pathway that can limit immune-cell activity against cancer cells. Cisplatin is a platinum-based chemotherapy medicine, and paclitaxel belongs to the taxane class of chemotherapy medicines. The Indian indication does not require patient selection based on programmed death-ligand 1 (PD-L1) expression.

Clinical Evidence and Regulatory Context

The approval is supported by the Phase 3 JUPITER-06 trial. In the trial, toripalimab with chemotherapy reduced the risk of disease progression or death by 42% compared with chemotherapy alone. Median overall survival was 17.7 months in the combination group and 12.9 months in the chemotherapy-alone group. These results refer to the trial groups and do not predict an individual patient’s outcome.

Important Facts for Exams

• The Central Drugs Standard Control Organisation (CDSCO) is India’s national regulatory authority for drugs and medical devices.
• The DCGI heads the CDSCO and carries out regulatory functions under the Drugs and Cosmetics Act, 1940.
• The US Food and Drug Administration, European Medicines Agency and UK Medicines and Healthcare products Regulatory Agency are regulatory authorities in the United States, European Union and United Kingdom, respectively.
• Dr. Reddy’s Laboratories entered a licensing and commercialisation agreement with Junshi Biosciences in 2023 for toripalimab across 21 countries.

Toripalimab has also received approvals from the US Food and Drug Administration, the European Medicines Agency and the UK Medicines and Healthcare products Regulatory Agency.