Key Highlights:
- Dr. Reddy’s Laboratories has received CDSCO approval for Zytorvi (toripalimab) with cisplatin and paclitaxel as first-line treatment for adults with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC).
- Supported by the Phase III JUPITER-06 trial, the combination reduced the risk of disease progression or death by 42% versus chemotherapy alone. Median overall survival reached 17.7 months versus 12.9 months, with benefits across PD-L1 expression subgroups.
- The Indian approval does not require PD-L1-based patient selection, broadening eligibility regardless of biomarker status. Under a 2023 agreement with Junshi Biosciences covering 21 countries, Dr. Reddy’s aims to expand access to first-line immunotherapy for advanced ESCC in India.
Implications:
Zytorvi’s approval strengthens Dr. Reddy’s position in India’s esophageal cancer market by expanding access to first-line PD-1 immunotherapy without PD-L1-based selection. Improved overall survival could support adoption over chemotherapy alone, while competition with established immunotherapies, affordability and physician uptake will determine its commercial impact.
Source: Express Pharma
