Dr Reddy’s Laboratories (DRL) has received approval from India’s Central Drugs Standard Control Organisation (CDSCO) for Zytorvi (toripalimab), in combination with cisplatin and paclitaxel, as a first-line treatment for adults with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma (ESCC).
The approval provides an additional immunotherapy-based treatment option for eligible patients with advanced ESCC, a disease that accounts for approximately 80% of oesophageal cancer cases in India.
Notably, the approved indication does not require patient selection based on programmed death-ligand 1 (PD-L1) expression, allowing eligible patients to be considered for treatment irrespective of their biomarker status.
Clinical trial demonstrates survival benefit
The approval is supported by findings from the Phase 3 JUPITER-06 clinical trial, in which toripalimab, combined with paclitaxel and cisplatin, reduced the risk of disease progression or death by 42% compared with chemotherapy alone.
At the final overall survival analysis, median overall survival was 17.7 months for patients receiving toripalimab with chemotherapy, against 12.9 months for those receiving chemotherapy alone.
Clinical benefits were observed across different PD-L1 expression subgroups, supporting the treatment’s potential application without requiring selection based on this biomarker.
India represents a significant treatment market
Oesophageal cancer was the fourth-leading cause of cancer-related deaths in India in 2024, accounting for approximately 8.1% of all cancer deaths, according to the company.
ESCC is the predominant subtype of oesophageal cancer in the country, highlighting the potential significance of additional treatment options for patients with advanced disease.
Symptoms associated with oesophageal cancer can include progressive difficulty in swallowing, unexplained weight loss, discomfort while swallowing and persistent chest discomfort. These symptoms can also arise from other conditions and require medical evaluation.
Licensing agreement with Junshi Biosciences
Dr Reddy’s entered into a licensing and commercialisation agreement with Junshi Biosciences in 2023 for toripalimab across 21 countries.
The drug has also received regulatory approvals in international markets, including the US, the European Union and the UK. The European Medicines Agency’s approval covers first-line treatment of ESCC irrespective of PD-L1 expression.
Dr Reddy’s Laboratories Chief Executive Officer, Global Generics, M V Ramana 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,” Ramana added.
The approval expands Zytorvi’s approved uses in India and strengthens Dr Reddy’s presence in oncology, as the pharmaceutical company seeks to widen access to immunotherapy-based treatments.