HOME > MARKETS > COMPANY NEWS
  COMPANY NEWS
COMPANY
Dr. Reddy’s Laboratories gets nod for Zytorvi in advanced esophageal cancer
Oct-21-2026

Dr. Reddy’s Laboratories has received approval from Central Drugs Standard Control Organisation (CDSCO), under the Drugs Controller General of India (DCGI), for Zytorvi (toripalimab) in combination with cisplatin and paclitaxel for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC).

The company entered into a licensing and commercialization agreement with Junshi Biosciences in 2023 for toripalimab across 21 countries. Globally, Toripalimab is approved by regulatory authorities including the U.S. Food and Drug Administration (USFDA), the European Medicines Agency (EMA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). Notably, the EMA approval is for first-line treatment of ESCC irrespective of PD-L1 expression. The approved indication in India similarly does not require patient selection based on PD-L1 expression, enabling appropriate patients to be considered for treatment regardless of their biomarker status.

In 2024, esophageal cancer was the fourth leading cause of cancer-related death in India, accounting for around 8.1% of all cancer deaths. ESCC, the predominant subtype, accounts for approximately 80% of all esophageal cancer cases in India. Through Zytorvi, the company aims to expand access to first-line immunotherapy for appropriate patients with advanced ESCC in India. The approval is supported by the results from the Phase 3 JUPITER-06 trial. In the study, toripalimab in combination with paclitaxel and cisplatin reduced the risk of disease or death by 42% compared with chemotherapy alone. At the final overall-survival analysis, median overall survival was 17.7 months with toripalimab plus chemotherapy compared with 12.9 months with chemotherapy alone. Clinical benefit was observed across PD-L1-expression subgroups.

Dr. Reddy's Laboratories is a multinational pharmaceutical company based in Hyderabad, Telangana in India. It manufactures and markets a wide range of pharmaceuticals in India and overseas.

  RELATED NEWS >>