Dr. Reddy’s Laboratories has received approval from the Central Drugs Standard Control Organisation (CDSCO) in India for Zytorvi® (toripalimab). This approval marks the second indication for the drug in India and allows its use in combination with cisplatin and paclitaxel for the first-line treatment of adult patients with advanced esophageal squamous cell carcinoma (ESCC). This expansion is expected to broaden access to immunotherapy for patients with this prevalent cancer subtype.
New Indication for Zytorvi® in India
Dr. Reddy’s Laboratories Ltd. announced today that the Central Drugs Standard Control Organisation (CDSCO), under the Drugs Controller General of India (DCGI), has granted approval for Zytorvi® (toripalimab). This approval pertains to its use as a first-line treatment for adult patients suffering from unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC). The therapy is to be administered in combination with cisplatin and paclitaxel.
Expanding Access to Immunotherapy
This approval represents the second major indication for Zytorvi® in India, following its earlier clearance for nasopharyngeal carcinoma. The new indication is significant as esophageal cancer was identified as the fourth leading cause of cancer-related death in India in 2024, with ESCC accounting for approximately 80% of these cases. Dr. Reddy’s aims to enhance access to first-line immunotherapy for patients battling advanced ESCC, irrespective of PD-L1 expression, thereby enabling a wider patient population to benefit.
Clinical Trial Support
The approval is substantiated by positive results from the pivotal Phase 3 JUPITER-06 trial. This study demonstrated that toripalimab, when used in conjunction with paclitaxel and cisplatin, reduced the risk of disease progression or death by 42% compared to chemotherapy alone. The trial also reported a median overall survival of 17.7 months for the toripalimab arm versus 12.9 months for the chemotherapy-only arm.
Company Perspective
M.V. Ramana, Chief Executive Officer, Global Generics at Dr. Reddy’s Laboratories, stated, “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 esophageal squamous cell carcinoma. It gives physicians an additional first-line treatment option for appropriate patients.”
Source: BSE
