Business Economy


Dr. Reddy’s gets DCGI approval for Zytorvi in Advanced Oesophageal Cancer

Hyderabad, Oct 21 (UNI) Dr. Reddy’s Laboratories has received approval from the Drugs Controller General of India (DCGI) for Zytorvi (toripalimab), in combination with cisplatin and paclitaxel, for the first-line treatment of adults with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma (ESCC).
The approval marks the drug’s second approved indication in India, following its earlier approval for nasopharyngeal carcinoma, the Hyderabad based pharma giant said in a press release on Wednesday.
The approved treatment does not require patient selection based on PD-L1 expression, allowing eligible patients to be considered for therapy regardless of their biomarker status.
The approval is supported by findings from the Phase III JUPITER-06 clinical trial, in which toripalimab combined with chemotherapy reduced the risk of disease progression or death by 42 per cent compared with chemotherapy alone.
At the final overall survival analysis, median overall survival was 17.7 months for patients receiving toripalimab with chemotherapy, compared with 12.9 months for those receiving chemotherapy alone.
M.V. Ramana, Chief Executive Officer, Global Generics, Dr. Reddy’s Laboratories, said the approval would extend access to immunotherapy for patients with advanced oesophageal squamous cell carcinoma and provide physicians with an additional first-line treatment option.
The company entered into a licensing and commercialisation agreement with Shanghai Junshi Biosciences in 2023, securing exclusive rights to develop and commercialise toripalimab in 21 countries, including India.
Oesophageal cancer was the fourth leading cause of cancer-related deaths in India in 2024, accounting for approximately 8.1 per cent of all cancer deaths. Oesophageal squamous cell carcinoma accounts for around 80 per cent of oesophageal cancer cases in the country, the press added.
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