Dr. Reddy’s Laboratories has received Central Drugs Standard Control Organisation (CDSCO) approval for the use of Zytorvi (toripalimab) in the treatment of unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC).
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The approval from the body under the Drugs Controller General of India (DCGI) for use, in combination with cisplatin and paclitaxel, as the first-line treatment of adult patients with ESCC, expands the use of Shanghai Junshi Biosciences’ drug beyond the initially approved indication for nasopharyngeal carcinoma (NPC).
In 2023, Dr. Reddy’s entered into a licensing and commercialisation agreement with Junshi for toripalimab across 21 countries. The Hyderabad-headquartered generic drugmaker launched Zytorvi in November 2024 for recurrent or metastatic nasopharyngeal carcinoma, making India the third country in the world, after China and the U.S., to receive access to the medicine.
Globally, Toripalimab is approved by regulatory authorities, including the U.S. Food and Drug Administration (U.S. FDA), the European Medicines Agency (EMA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Fourth leading cause
In 2024, esophageal cancer was the fourth leading cause of cancer-related death in India, accounting for approximately 8.1% of all cancer deaths. ESCC, the predominant subtype, accounts for approximately 80% of all esophageal cancer cases in India. Through Zytorvi, the aim is to expand access to first-line immunotherapy for appropriate patients with advanced ESCC in India, Dr. Reddy’s Laboratories said on Wednesday, October 21, 2026.
On the latest approval, Dr. Reddy’s CEO, Global Generics M.V. Ramana, said it is an important step in extending the reach of immunotherapy to patients with advanced ESCC. “As we continue to build our oncology portfolio, the focus remains on bringing meaningful advances and expanding access to innovative treatment options,” he said.
Published - October 21, 2026 12:32 pm IST