Business · India Bureau
Dr Reddy's wins regulator nod for cancer drug's new indication
The pharmaceutical firm has secured approval from India's drug regulator to use toripalimab in combination therapy for advanced esophageal cancer. The clearance expands the immunotherapy's therapeutic applications in the country's oncology space.
LSN India ·
Dr Reddy's Laboratories has received approval from the Drugs Controller General of India (DCGI) to market toripalimab with cisplatin and paclitaxel for treating advanced esophageal squamous cell carcinoma (ESCC), marking the drug's second approved indication in India.
The combination therapy has been cleared as a first-line treatment option for patients with unresectable advanced, recurrent, or metastatic ESCC. This regulatory green light enables the company to commercialise the immunotherapy-based regimen for a patient population with limited treatment alternatives and significant clinical need.
ESCC remains a significant health burden in India and across South Asia, with high mortality rates and limited effective therapeutic options. The approval of this combination approach provides oncologists with an additional evidence-based treatment strategy for managing the disease at advanced stages.
The clearance follows the drug's earlier approval in India for a different indication, broadening its utility within the country's cancer treatment landscape. Toripalimab, a PD-1 inhibitor, works by enhancing the immune system's ability to target cancer cells, a mechanism that has demonstrated efficacy in multiple solid tumours.