Dr Reddy's gets DCGI approval for Zytorvi to treat advanced esophageal cancer
The Indian regulator has cleared toripalimab for first-line treatment of advanced esophageal squamous cell carcinoma, broadening access to advanced immunotherapy.
Dr Reddy's Laboratories has received approval from the Drugs Controller General of India to market Zytorvi for the treatment of advanced esophageal squamous cell carcinoma, expanding the country's access to state-of-the-art oncological therapies.
The Central Drugs Standard Control Organisation granted clearance for the drug, known generically as toripalimab, to be used alongside cisplatin and paclitaxel as a first-line treatment for adult patients suffering from unresectable advanced, recurrent, or metastatic forms of the disease.
The clearance marks a major step in strengthening national healthcare infrastructure and expanding modern therapeutic options for severe oncological conditions in India.
Clinical impact and trial results
Zytorvi is a monoclonal antibody designed to block the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby restoring the ability of the immune system's T-cells to attack cancer cells.
Approval for the new indication was granted following key data from the Phase 3 JUPITER-06 clinical trial. The study demonstrated that combining toripalimab with standard chemotherapy markedly improved patient outcomes compared to chemotherapy alone.
| Treatment regimen | Median overall survival | Risk reduction in death or disease progression |
|---|---|---|
| Toripalimab + Chemotherapy | 17.7 months | 42 per cent |
| Chemotherapy alone | 12.9 months | Baseline |
Addressing India's oncology burden
Esophageal cancer presents a significant public health challenge in India, where it ranked as the fourth leading cause of cancer-related mortality in 2024 and accounted for roughly 8.1 per cent of all cancer deaths. Esophageal squamous cell carcinoma is the predominant subtype, representing about 80 per cent of all esophageal cancer diagnoses across the country.
This approval represents the second indication for Zytorvi in India. Dr Reddy's initially launched the medicine in November 2024 to treat recurrent or metastatic nasopharyngeal carcinoma, making India the third country globally, following China and the United States, to provide access to the treatment.
Dr Reddy's CEO of Global Generics, M.V. Ramana, stated that the clearance serves as an important milestone in extending advanced immunotherapy to patients facing advanced esophageal cancer, reflecting an ongoing effort to bring meaningful treatment innovations to domestic patients.
Global licensing and regulatory standing
The Hyderabad-based pharmaceutical company secured commercialisation rights for toripalimab across 21 countries under a licensing agreement signed in 2023 with Shanghai Junshi Biosciences, the original developer of the molecule. Beyond India, toripalimab has earned regulatory authorizations from international bodies including the United States Food and Drug Administration, the European Medicines Agency, and the United Kingdom Medicines and Healthcare products Regulatory Agency.
Key numbers
| What | Figure | Source |
|---|---|---|
| Reduction in disease progression or death risk | 42 per cent | Dr. Reddy's Laboratories statement on JUPITER-06 trial results |
| Median overall survival with Toripalimab combination | 17.7 months | Dr. Reddy's Laboratories statement on JUPITER-06 trial results |
| Median overall survival with chemotherapy alone | 12.9 months | Dr. Reddy's Laboratories statement on JUPITER-06 trial results |
| Share of ESCC in Indian esophageal cancer cases | 80 per cent | Dr. Reddy's Laboratories statement |
| Esophageal cancer proportion of 2024 Indian cancer deaths | 8.1 per cent | Dr. Reddy's Laboratories statement |
In this story
| Name | Role in the story |
|---|---|
| India | Country where approval was granted and disease statistics apply. |
| Dr. Reddy's Laboratories | Pharmaceutical company receiving approval to market Zytorvi for esophageal cancer. |
| Central Drugs Standard Control Organisation | National regulatory body under the DCGI approving the drug. |
| Drugs Controller General of India | Indian national regulatory authority granting market approval. |
