DCGI Approves Zytorvi (Toripalimab) for Advanced Esophageal Cancer

On October 21, 2026, the Drugs Controller General of India (DCGI) approved Zytorvi (toripalimab) in combination with cisplatin and paclitaxel for the first-line treatment of adults with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC). As communicated by Dr. Reddy’s Laboratories, this decision was made following Zytorvi’s first indication for use in India, which included its approval for use in nasopharyngeal carcinoma. This decision has been supported by the data obtained during the Phase 3 JUPITER-06 trial.

What Is Zytorvi (Toripalimab)?

Zytorvi is an immunotherapy drug that contains toripalimab. It is a monoclonal antibody against programmed cell death protein 1 (PD-1) that acts as an immune checkpoint receptor. Inhibiting the PD-1 pathway enables the immune system to identify and destroy cancer cells.

This combination therapy comprises two chemotherapeutic drugs: cisplatin and paclitaxel. It is indicated for adults with unresectable advanced, recurrent, or metastatic ESCC. As per the Indian indication, there is no need for patient selection on the basis of programmed death-ligand 1 (PD-L1) expression.

Definition of Esophageal Squamous Cell Carcinoma (ESCC)

The oesophagus is a hollow muscular tube that transfers the food material from the mouth to the stomach. Esophageal cancer occurs due to the formation of cancerous cells within the tissues of this organ.

ESCC arises from the squamous cells present in the inner lining of the oesophagus. According to the provided report, ESCC makes up about 80% of the total number of esophageal cancer cases in India.

Medical terms used in the approved indication are,

• Unresectable: A tumor which is not removable via surgery.
• Advanced: This term indicates an advanced stage of cancer.
• Recurrent: The term is used to indicate cancer that recurs.
• Metastatic: It means cancer spread to distant body organs.
• First-line treatment: The first treatment modality for the disease setting.

How Does the Combination Therapy Work?

This combination therapy uses an immunotherapy medication alongside two chemotherapy medications.

Medication	Drug category	Function
Toripalimab	Monoclonal antibody, PD-1 inhibitor	Stimulates the immune system to fight cancer cells
Cisplatin	Platinum-based chemotherapy	Causes damage to the DNA of cancer cells
Paclitaxel	Taxane chemotherapy	Prevents cancer cell division

Various mechanisms are involved in this combination therapy to fight cancer. Professional healthcare practitioners must assess the effectiveness of the therapy and any side effects it may have.

Clinical Evidence – JUPITER-06 Study

The approval of this drug combination for treating advanced or metastatic ESCC is based on the Phase 3 JUPITER-06 study, which evaluated this combination therapy in patients with advanced or metastatic ESCC.

Clinical Outcome	Toripalimab + chemotherapy	Chemotherapy only
Overall survival time	17.7 months	12.9 months
Relative risk of disease progression or death	Lower relative risk (42%)	Reference group

The combination therapy had a median overall survival of 17.7 months compared to 12.9 months for chemotherapy-only therapy. The 42% lower relative risk of disease progression or death relates to the risk in the reference group during the clinical trial; it is not a guaranteed outcome.