Dr Reddy’s Secures DCGI Approval for Zytorvi in Advanced Esophageal Cancer

Dr Reddy’s Laboratories has obtained regulatory clearance from the Drug Controller General of India (DCGI) for its immunotherapy drug Zytorvi (toripalimab) to be used as a first-line treatment for adults diagnosed with advanced oesophageal squamous cell carcinoma (ESCC). This authorization marks an extension of the drug's application beyond its initial indication for nasopharyngeal carcinoma within the Indian market.

The approval, granted by the Central Drugs Standard Control Organisation (CDSCO), permits the use of toripalimab in combination with chemotherapy agents cisplatin and paclitaxel. This treatment is intended for patients who have unresectable advanced, recurrent, or metastatic ESCC, offering a new therapeutic option for this challenging cancer type.

Zytorvi’s recent nod is the second indication approved for the drug in India after its initial launch in November 2024 targeting recurrent or metastatic nasopharyngeal carcinoma. Dr Reddy’s secured exclusive rights to develop and market toripalimab across 21 countries through a licensing agreement signed with Shanghai Junshi Biosciences in 2023.

The DCGI’s decision is backed by data from the Phase III JUPITER-06 clinical trial. This study demonstrated that toripalimab combined with chemotherapy reduced the risk of disease progression or death by 42 percent compared to chemotherapy alone. At the final overall survival analysis, patients treated with the combination therapy had a median survival of 17.7 months, whereas those receiving only chemotherapy had a median survival of 12.9 months.

Importantly, the clinical benefits of toripalimab were observed across various patient groups regardless of their PD-L1 expression levels—a biomarker often used to guide immunotherapy treatments. The regulatory approval in India does not mandate patient selection based on PD-L1 status, potentially broadening access to treatment for eligible ESCC patients without biomarker restriction.

M V Ramana, Chief Executive Officer of Global Generics at Dr Reddy’s Laboratories, highlighted the significance of this approval, stating, "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."

Oesophageal cancer represents a considerable health burden in India. According to Dr Reddy’s citing estimates from the International Agency for Research on Cancer, oesophageal cancer ranked as the fourth-leading cause of cancer-related deaths in India in 2024, accounting for approximately 8.1 percent of such fatalities. Among these cases, ESCC constitutes nearly 80 percent.

Toripalimab is a humanized monoclonal antibody that targets programmed death receptor-1 (PD-1), a checkpoint protein that plays a critical role in downregulating immune responses. By inhibiting the interaction between PD-1 and its ligands, toripalimab reactivates T-cells, enabling them to recognize and attack cancer cells effectively.

On a global scale, toripalimab has secured approvals from several major regulatory bodies, including the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA). This international recognition further underscores the drug’s therapeutic potential in various cancer types.

The expansion of Zytorvi’s approved uses in India reflects a broader trend in oncology focused on integrating immunotherapy with conventional chemotherapy to improve outcomes for patients with aggressive cancers. As treatment options evolve, this approval provides hope for improved survival and quality of life for individuals battling advanced oesophageal squamous cell carcinoma in India.