Dr. Reddy's Gets India Nod For Zytorvi In Esophageal Cancer, Citing 42% Lower Risk Of Disease Or Death
The company's immunotherapy now has a second approved use in India, with survival of 17.7 months versus 12.9 on chemotherapy alone.
India's drug regulator has approved Dr. Reddy's immunotherapy Zytorvi (toripalimab) for a second cancer, advanced esophageal squamous cell carcinoma, the company said in a Wednesday statement furnished to the SEC. The approval covers first-line use alongside the chemotherapy drugs cisplatin and paclitaxel.
What the approval covers
The Central Drugs Standard Control Organisation, under the Drugs Controller General of India, cleared Zytorvi for adults with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma, the company said. The approval letter is dated September 24, 2026, according to the release's references.
The approved use does not require patients to be selected by PD-L1 expression, a biomarker test, so patients can be considered regardless of status. The release notes that the European Medicines Agency's approval for first-line use in this cancer is likewise irrespective of PD-L1 expression.
It is the drug's second indication in India. Dr. Reddy's launched Zytorvi there in November 2024 for recurrent or metastatic nasopharyngeal carcinoma.
The trial numbers
The approval rests on the late-stage JUPITER-06 trial. Toripalimab plus paclitaxel and cisplatin reduced the risk of disease or death by 42% compared with chemotherapy alone, the company said.
In the final survival analysis, median overall survival was 17.7 months with the combination versus 12.9 months with chemotherapy alone. The release says clinical benefit appeared across PD-L1 subgroups.
The company put the need in context: esophageal cancer was India's fourth leading cause of cancer death in 2024, about 8.1% of all cancer deaths. The squamous subtype makes up about 80% of esophageal cancer cases in India.
What it means for Dr. Reddy's
Dr. Reddy's holds exclusive rights to develop and sell toripalimab in 21 countries under a 2023 agreement with Shanghai Junshi Biosciences. M.V. Ramana, Chief Executive Officer of Global Generics, said the approval gives physicians "an additional first-line treatment option for appropriate patients."
The company's U.S.-listed shares closed at $13.26 on Tuesday, before the release, for a market value of $11.0 billion.
The release names no launch date for the new indication; the approval letter itself is dated September 24, 2026.
