Hyderabad/Mumbai, Oct 21 — Dr Reddy's Laboratories has received approval from the Drug Controller General of India (DCGI), through the Central Drugs Standard Control Organisation (CDSCO), 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 company announced on Wednesday, October 21. HDFC Sky reported the announcement from the company's exchange filing, TaxGuru published the company's release, and The Hindu BusinessLine carried the approval in its October 21 market coverage.

Second indication in India: The approval is Zytorvi's second approved use in India, after recurrent or metastatic nasopharyngeal carcinoma. The ESCC approval does not require patient selection based on PD-L1 expression, the company said. Zytorvi is a monoclonal antibody that targets the PD-1 receptor, helping the immune system respond against cancer cells. Dr Reddy's holds rights to toripalimab under a 2023 licensing and commercialisation agreement with Shanghai Junshi Biosciences covering 21 countries, including India.

What the trial showed: The approval is supported by the Phase 3 JUPITER-06 trial. According to the company, toripalimab plus cisplatin and paclitaxel reduced the risk of disease progression or death by 42% compared with chemotherapy alone, and at the final overall-survival analysis the median overall survival was 17.7 months with the combination versus 12.9 months with chemotherapy alone. The company said the benefit was seen across PD-L1-expression subgroups.

Why it matters in India: Oesophageal cancer was the fourth leading cause of cancer-related deaths in India in 2024, according to the company's release reported by TaxGuru and FilingReader, accounting for about 8.1% of cancer fatalities. The approval expands first-line immunotherapy access for eligible patients with advanced ESCC. The company did not disclose an expected revenue contribution from the new indication, HDFC Sky noted.

Sources: Dr Reddy's Laboratories announcement via HDFC Sky (Oct 21, 2026, citing the NSE filing dated Oct 21, 2026); TaxGuru (Oct 21, 2026), publishing the company release; The Hindu BusinessLine market live coverage (Oct 21, 2026, 09:48 IST); Kalkine India (Oct 21, 2026).