Dr. Reddy’s Laboratories has received approval from the Central Drugs Standard Control Organisation (CDSCO), under the Drugs Controller General of India (DCGI), for Zytorvi® (toripalimab) in combination with cisplatin and paclitaxel as a first-line treatment for adults with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC).
This marks the drug’s second approved indication in India, following its approval for nasopharyngeal carcinoma. The company had entered into a licensing and commercialisation agreement with Junshi Biosciences in 2023 to market toripalimab across 21 countries.
Toripalimab has also received approvals from regulatory authorities in the US, Europe and the UK. The newly approved Indian indication does not require patient selection based on PD-L1 expression, allowing eligible patients to be considered for treatment regardless of their biomarker status.
According to the company, esophageal cancer was the fourth-leading cause of cancer-related deaths in India in 2024, accounting for approximately 8.1% of such deaths. ESCC is the predominant subtype, representing around 80% of esophageal cancer cases in the country.
The approval is supported by findings from the Phase 3 JUPITER-06 clinical trial. The study showed that toripalimab, combined with paclitaxel and cisplatin, reduced the risk of disease progression or death by 42% compared with chemotherapy alone. At the final overall survival analysis, median overall survival stood at 17.7 months for patients receiving the combination therapy, compared with 12.9 months for those receiving chemotherapy alone. Clinical benefits were observed across different PD-L1 expression subgroups.
M.V. Ramana, Chief Executive Officer of Global Generics at Dr. Reddy’s Laboratories, said the approval expands the reach of immunotherapy to patients with advanced ESCC and provides physicians with an additional first-line treatment option. He added that the company remains focused on strengthening its oncology portfolio and improving access to innovative therapies.