Dr Reddy’s Laboratories has received approval from the Drug 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), expanding the drug’s use beyond nasopharyngeal cancer in India.
The approval by the Central Drugs Standard Control Organisation (CDSCO) covers the use of toripalimab in combination with the chemotherapy drugs cisplatin and paclitaxel for patients with unresectable advanced, recurrent or metastatic ESCC.
This is the drug’s second approved indication in India, following its launch in November 2024 for recurrent or metastatic nasopharyngeal carcinoma.
Dr Reddy’s has exclusive rights to develop and commercialise toripalimab in 21 countries under a licensing agreement signed with Shanghai Junshi Biosciences in 2023.
The approval for ESCC is supported by results from the Phase III JUPITER-06 clinical trial.
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The study found that toripalimab, when administered with chemotherapy, reduced the risk of disease progression or death by 42 per cent compared with chemotherapy alone.
At the final overall survival analysis, median survival was 17.7 months among patients receiving the combination treatment, compared with 12.9 months for those receiving chemotherapy alone.
Clinical benefits were observed across patient groups with different levels of PD-L1 expression, a biomarker used in cancer treatment decisions.
The Indian approval does not require patient selection based on PD-L1 expression, potentially allowing eligible patients to be considered for treatment irrespective of biomarker status.
“Following the approval of Zytorvi in nasopharyngeal carcinoma, this second indication marks an important step in extending the reach of immunotherapy to patients with advanced oesophageal squamous cell carcinoma,” said M V Ramana, chief executive officer, global generics, Dr Reddy’s Laboratories.
The company’s expansion into ESCC comes amid the significant disease burden in India.
Oesophageal cancer was the fourth-leading cause of cancer-related deaths in the country in 2024, accounting for approximately 8.1 per cent of such deaths, according to the company, citing estimates from the International Agency for Research on Cancer.
ESCC accounts for around 80 per cent of oesophageal cancer cases in India.
Toripalimab is a humanised monoclonal antibody that targets programmed death receptor-1 (PD-1), a protein involved in regulating immune responses.
By blocking the interaction between PD-1 and its ligands, the drug helps enable T-cells to attack cancer cells.
Globally, toripalimab has received approvals from regulators including the US Food and Drug Administration, the European Medicines Agency and the UK’s Medicines and Healthcare products Regulatory Agency.