Dr Reddy's receives DCGI approval for Zytorvi combo therapy in advanced esophageal cancer
India's drug regulator has approved Zytorvi, used with cisplatin and paclitaxel, as a first-line treatment for adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma.
The Drug Controller General of India (DCGI) has granted approval for Zytorvi in combination with cisplatin and paclitaxel as a first-line option for adults with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC). This clearance follows the drug's earlier approval for nasopharyngeal carcinoma, making it the second indication for Zytorvi in India. Results from the phase 3 JUPITER-06 study showed that toripalimab plus chemotherapy reduced the risk of disease progression or death by 42% relative to chemotherapy alone, and extended median overall survival to 17.7 months versus 12.9 months with chemotherapy only.
ESCC accounts for roughly 80% of esophageal cancer cases in the country, underscoring the therapy's potential impact. Dr Reddy's commercializes toripalimab across 21 nations under a 2023 agreement with Junshi Biosciences. Co-Chairman and MD GV Prasad highlighted the drug's role in the company's growth strategy.
Why it matters
The approval offers a new, effective first-line option for the majority of esophageal cancer patients in India.
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