Hyderabad, October 21: Pharma major Dr. Reddy’s Laboratories Limited has secured the approval of the Drugs Controller General of India (DCGI)’s Central Drugs Standard Control Organisation (CDSCO) for its Zytorvi (toripalimab) drug to treat a variant of Esophageal cancer called esophageal squamous cell carcinoma (ESCC). This approval is supported by the results of the Phase 3 JUPITER-06 trial, where the drug, along with cisplatin and paclitaxel, reduced the risk of disease or death by 42% compared to chemotherapy alone.
Esophageal cancer has been the fourth leading cause of cancer-related deaths in India, accounting for about 8.1% of all cancer deaths. Poor diet, smokeless and smoked tobacco uise, alcohol consumption and certain environmental and socioeconomic factors have been the main risk factors for esophageal cancer. ESCC remains the predominant variant, accounting for about 80% of all esophageal cancer cases in India. Through Zytorvi, Dr. Reddy’s is aiming to expand access to the drug through its network, benefiting millions of patients pan-India.
Globally, toripalimab has been approved by the U.S. Food and Drug Administration (USFDA), the European Medicines Agency (EMA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). With this approval in India, the drug doesn’t require patient selection on PD-L1 markers for ESCC, allowing appropriate patients to be treated regardless of their biomarker status.
“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.” M.V. Ramana, Chief Executive Officer, Global Generics, Dr. Reddy’s Laboratories, said in a press release.
