Dr Reddy’s Gets DCGI Nod for Zytorvi in Advanced Oesophageal Cancer
The approval marks the drug’s second indication in India, following its earlier approval for nasopharyngeal carcinoma, the Hyderabad-based pharmaceutical company said on Wednesday.
The approved indication does not require patient selection based on PD-L1 expression, allowing eligible patients to receive the treatment irrespective of their biomarker status.
The approval is supported by results from the Phase III JUPITER-06 trial, in which toripalimab in combination with chemotherapy reduced the risk of disease progression or death by 42 per cent compared with chemotherapy alone.
The final overall survival analysis showed a median survival of 17.7 months among patients receiving toripalimab with chemotherapy, compared with 12.9 months among those receiving chemotherapy alone.
Clinical benefits were observed across PD-L1 expression subgroups.
M.V. Ramana, Chief Executive Officer, Global Generics, Dr Reddy’s Laboratories, said the approval would provide physicians with an additional first-line treatment option for patients with advanced oesophageal squamous cell carcinoma.
Dr Reddy’s 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 accounted for approximately 8.1 per cent of all cancer deaths in India in 2024, while ESCC constitutes around 80 per cent of oesophageal cancer cases in the country, according to the company.
