Dr. Reddy’s Laboratories Ltd. has announced the approval of Zytorvi® (toripalimab) by the Central Drugs Standard Control Organisation (CDSCO) for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) in India. This approval marks the second indication for Zytorvi® in India, following its earlier approval for nasopharyngeal carcinoma. The approval allows for the use of Zytorvi® in combination with cisplatin and paclitaxel, without the need for patient selection based on PD-L1 expression.
The decision by the CDSCO is supported by the positive results from the Phase 3 JUPITER-06 trial, which demonstrated that toripalimab, when combined with paclitaxel and cisplatin, reduced the risk of disease progression or death by 42% compared to chemotherapy alone. The median overall survival for patients receiving the combination therapy was 17.7 months, compared to 12.9 months for those receiving only chemotherapy. The clinical benefits of toripalimab were observed across different PD-L1-expression subgroups, indicating its efficacy regardless of biomarker status.
Dr. Reddy’s Laboratories entered into a licensing and commercialisation agreement with Junshi Biosciences in 2023, granting them exclusive rights to develop and market toripalimab in 21 countries, including India. Toripalimab has already received approvals from major regulatory authorities such as the U.S. Food and Drug Administration, the European Medicines Agency, and the UK Medicines and Healthcare products Regulatory Agency. The approval in India is expected to enhance access to first-line immunotherapy for patients with advanced ESCC, a significant step given that esophageal cancer was the fourth leading cause of cancer-related deaths in India in 2024.
M.V. Ramana, Chief Executive Officer, Global Generics at Dr. Reddy’s Laboratories, expressed that the approval of Zytorvi® for ESCC represents a crucial advancement in extending immunotherapy options to patients. As the company continues to expand its oncology portfolio, the focus remains on providing innovative treatment options that offer meaningful benefits to patients.
Analysts view this approval as a strategic move for Dr. Reddy’s Laboratories, potentially strengthening its position in the oncology market and enhancing its global footprint. The development aligns with the company’s commitment to expanding access to affordable and innovative medicines, particularly in regions with high unmet medical needs.
