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DCGI Approves Toripalimab Combination Therapy for Advanced Oesophageal Cancer in India

India has approved a new treatment option for adults with advanced oesophageal squamous cell carcinoma (ESCC), with the Drugs Controller General of India (DCGI) clearing Zytorvi, the toripalimab-based immunotherapy developed by Dr Reddy’s Laboratories, for use in combination with chemotherapy.

The approval, dated October 21, 2026, covers adults with unresectable advanced, recurrent or metastatic ESCC. The combination pairs toripalimab, an immune checkpoint inhibitor, with cisplatin and paclitaxel, two established chemotherapy drugs.

Why the approval matters

Oesophageal cancer develops in the tube connecting the throat to the stomach. ESCC originates in the squamous cells lining the oesophagus and is a major form of the disease in India.

The approval applies to patients whose cancer cannot be removed surgically, has returned after earlier treatment, or has spread to other parts of the body. In this setting, first-line treatment refers to the initial systemic therapy used for advanced disease.

Toripalimab belongs to a class of medicines known as immune checkpoint inhibitors. It targets programmed cell death protein 1 (PD-1), a receptor involved in regulating immune responses. Blocking this pathway can help immune cells recognise and attack cancer cells.

The combination uses three different mechanisms. Toripalimab helps restore an anti-tumour immune response, cisplatin damages cancer-cell DNA, and paclitaxel interferes with cell division. The aim is to combine immune-system activity with chemotherapy to improve disease control.

According to the approved Indian indication described in the announcement, treatment does not require patient selection based on programmed death-ligand 1 (PD-L1) expression. This may simplify one aspect of treatment eligibility, although decisions about suitability remain the responsibility of the treating oncology team.

Phase 3 evidence behind the decision

The decision expands the approved use of toripalimab in India, following its earlier indication for nasopharyngeal carcinoma. It also brings an immunotherapy-based combination into the first-line treatment landscape for a cancer in which disease progression and limited treatment options can pose substantial challenges.

The approval is supported by the Phase 3 JUPITER-06 clinical trial, which evaluated toripalimab combined with chemotherapy against chemotherapy alone in patients with advanced or metastatic ESCC.

The reported results showed a median overall survival of 17.7 months for patients receiving toripalimab with chemotherapy, compared with 12.9 months for those receiving chemotherapy alone.

The study also reported a 42% reduction in the relative risk of disease progression or death for the combination compared with chemotherapy alone.

These findings suggest that adding toripalimab improved outcomes in the trial population. However, the relative risk reduction should not be interpreted as a 42-percentage-point increase in survival or as a guarantee that an individual patient will experience the same benefit.

Median overall survival is a population-level measure: half the patients in a study group lived longer than the median, while half lived for less time. Individual outcomes can vary depending on disease characteristics, general health, treatment tolerance and other clinical factors.

The figures provided in the announcement do not include the full trial data, adverse-event rates or detailed subgroup results. A complete assessment of the treatment’s clinical profile requires consideration of those findings alongside the survival results.

Balancing treatment benefits and risks

The combination brings together immunotherapy and chemotherapy, but the approach also requires careful monitoring.

Toripalimab can cause immune-related adverse reactions when the immune system affects healthy organs. Cisplatin and paclitaxel can produce chemotherapy-related toxicities, which may include nausea, blood-cell abnormalities and nerve-related complications, depending on the patient and treatment regimen.

The balance between potential benefit and risk must therefore be assessed by qualified oncologists. The regulatory approval establishes the permitted use of the combination for the specified indication; it does not mean that every patient with advanced ESCC will be suitable for treatment.

What the approval means for oncology care

For Dr Reddy’s Laboratories, the expanded indication broadens the clinical use of Zytorvi in India. For patients and oncologists, it introduces another approved option for first-line treatment of advanced ESCC, backed by Phase 3 evidence.

The practical impact will depend on factors including access, affordability, treatment availability and the ability of healthcare teams to manage adverse effects. The supplied announcement does not specify the medicine’s Indian launch price or the expected cost of a complete course of treatment.

The approval is a regulatory milestone, but its wider significance will be determined by how the treatment is incorporated into clinical practice and whether eligible patients can access it.

For advanced oesophageal cancer, where treatment decisions often involve difficult trade-offs between disease control, side effects and quality of life, the new indication adds another evidence-based option to the therapeutic landscape.

By Subramanya Joshi