Dr. Reddy’s Laboratories announced that the Central Drugs Standard Control Organisation (CDSCO), under the Drugs Controller General of India (DCGI), has approved Zytorvi (toripalimab) in combination with cisplatin and paclitaxel for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC).
Dr. Reddy’s entered into a licensing and commercialisation agreement with Junshi Biosciences in 2023 for toripalimab across 21 countries. Globally, toripalimab is approved by regulatory authorities including the US Food and Drug Administration (USFDA), the European Medicines Agency (EMA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). The EMA approval is for the first-line treatment of ESCC irrespective of PD-L1 expression. The approved indication in India similarly does not require patient selection based on PD-L1 expression, enabling appropriate patients to be considered for treatment regardless of their biomarker status.
In 2024, esophageal cancer was the fourth leading cause of cancer-related death in India, accounting for approximately 8.1 per cent of all cancer deaths. ESCC, the predominant subtype, accounts for approximately 80 per cent of all esophageal cancer cases in India. Through Zytorvi, Dr. Reddy’s Laboratories aims to expand access to first-line immunotherapy for appropriate patients with advanced ESCC in India.
The approval is supported by results from the Phase 3 JUPITER-06 trial. In the study, toripalimab in combination with paclitaxel and cisplatin reduced the risk of disease or death by 42 per cent compared with chemotherapy alone. At the final overall survival analysis, median overall survival was 17.7 months with toripalimab plus chemotherapy, compared with 12.9 months with chemotherapy alone. Clinical benefit was observed across PD-L1 expression subgroups.
M.V. Ramana, Chief Executive Officer, Global Generics, Dr. Reddy’s Laboratories, said, “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. As we continue to build our oncology portfolio, our focus remains on bringing meaningful advances and expanding access to innovative treatment options.”
Esophageal cancer begins in the tissues of the esophagus, the muscular tube that carries food and liquids from the throat to the stomach. ESCC develops from the squamous cells lining the esophagus.
Risk factors associated with ESCC include smoked and smokeless tobacco, alcohol consumption, areca-nut use, consumption of very hot beverages, poor diet, and certain environmental and socioeconomic factors. Risk varies between individuals, and the presence of one or more risk factors does not mean that a person will necessarily develop cancer.
Progressive difficulty in swallowing, pain or discomfort when swallowing, unexplained weight loss, persistent chest discomfort and regurgitation may be associated with esophageal cancer. These symptoms may also be caused by other conditions and require evaluation by a qualified healthcare professional.