Hyderabad: Dr Reddy’s Laboratories said on Wednesday that the Indian drug regulator has approved Zytorvi, its toripalimab, with cisplatin and paclitaxel as a first-line treatment for adults with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma (ESCC).The approval by the Central Drugs Standard Control Organisation (CDSCO), under the Drugs Controller General of India (DCGI), gives Zytorvi its second indication in the country after recurrent or metastatic nasopharyngeal carcinoma. Dr Reddy’s had licensed toripalimab from Shanghai Junshi Biosciences in 2023 for development and commercialisation across 21 countries.The company said the Indian indication does not require patient selection based on PD-L1 expression, aligning with European approval for first-line ESCC. Toripalimab is also approved by regulators including US Food and Drug Administration (USFDA), European Medicines Agency (EMA) and UK Medicines and Healthcare products Regulatory Agency (UK-MHRA).The CDSCO approval was supported by the Phase 3 JUPITER-06 trial, where toripalimab plus chemotherapy cut the risk of disease progression or death by 42% versus chemotherapy alone. Median overall survival was 17.7 months, compared with 12.9 months, the company said.MV Ramana, CEO, global generics, Dr Reddy’s Laboratories, said after the approval of Zytorvi for nasopharyngeal carcinoma, this second indication marks an important step in extending the reach of immunotherapy to patients with advanced ESCC and gives physicians an additional first-line treatment option for appropriate patients.Oesophageal cancer was India’s fourth leading cause of cancer-related death in 2024, representing about 8.1% of cancer deaths. ESCC accounts for around 80% of Indian oesophageal cancer cases.
