Approval Details

  • Drug Name: Zytorvi® (toripalimab)
  • Approved Indication: In combination with cisplatin and paclitaxel for first-line treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC)
  • Approval Authority: CDSCO under DCGI
  • Approval Reference: Letter No. BIO/IMP/25/000057, dated 24th September 2026
  • Key Feature: Approval does not require patient selection based on PD-L1 expression, enabling treatment regardless of biomarker status

Strategic Context

This marks the second approved indication for Zytorvi® in India, expanding beyond its initially approved indication in nasopharyngeal carcinoma (NPC). Dr. Reddy's entered into a licensing and commercialization agreement with Junshi Biosciences in 2023 for toripalimab across 21 countries including India, South Africa, Brazil, and several Latin American countries, Australia, New Zealand, and nine other countries.

Clinical Background

  • Medical Significance: Esophageal cancer was the fourth leading cause of cancer-related death in India in 2024, accounting for approximately 8.1% of all cancer deaths
  • Subtype Prevalence: ESCC accounts for approximately 80% of all esophageal cancer cases in India
  • Supporting Trial: Phase 3 JUPITER-06 trial
  • Clinical Results: Toripalimab in combination with paclitaxel and cisplatin reduced risk of disease or death by 42% compared with chemotherapy alone
  • Survival Data: Median overall survival was 17.7 months with toripalimab plus chemotherapy compared with 12.9 months with chemotherapy alone
  • Patient Benefit: Clinical benefit was observed across PD-L1-expression subgroups

Global Regulatory Status

Toripalimab is approved by regulatory authorities including:

  • U.S. Food and Drug Administration (USFDA)
  • European Medicines Agency (EMA) - approved for first-line treatment of ESCC irrespective of PD-L1 expression (September 2024)
  • UK Medicines and Healthcare products Regulatory Agency (MHRA)

Management Commentary

M.V. Ramana, Chief Executive Officer, Global Generics, Dr. Reddy's Laboratories, stated: "Following the approval of Zytorvi® in nasopharyngeal carcinoma, this second indication marks an important step in extending the reach of immunotherapy to patients with advanced esophageal squamous cell carcinoma. It gives physicians an additional first-line treatment option for appropriate patients. As we continue to build our oncology portfolio, our focus remains on bringing meaningful advances and expanding access to innovative treatment options."

Product Background

Zytorvi® contains toripalimab, a next-generation humanised IgG4 monoclonal antibody directed against programmed death receptor-1 (PD-1). By binding to PD-1, toripalimab blocks its interaction with PD-L1 and PD-L2, supporting T-cell activity against cancer cells.

Previous Launch History

Dr. Reddy's launched Zytorvi® in India in November 2024 for recurrent or metastatic nasopharyngeal carcinoma, making India the third country in the world (after China and United States) to receive access to the medicine.