CSPC's Duoenyi approved for first-line pancreatic cancer treatment in China

CSPC Pharmaceutical Group Limited announced that its irinotecan hydrochloride liposome injection, Duoenyi, has obtained marketing approval from China's National Medical Products Administration for a new indication. This approval is for the use of Duoenyi in combination with oxaliplatin, 5-fluorouracil (5-FU), and leucovorin (LV) as a first-line treatment for patients with metastatic pancreatic cancer. This marks Duoenyi's second approved indication in China and the first for an irinotecan liposomal injection for first-line pancreatic cancer treatment domestically.

The approval is based on a pivotal clinical study demonstrating that Duoenyi significantly prolonged progression-free survival (PFS) in advanced pancreatic cancer. Results presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting showed a hazard ratio (HR) of 0.55, indicating a 45% reduction in the risk of disease progression or death. The study also highlighted improved safety and efficacy compared to conventional formulations.

Duoenyi was initially approved in China on September 15, 2023, for metastatic pancreatic cancer patients who had progressed after gemcitabine treatment. CSPC is currently conducting a pivotal Phase III clinical trial for Duoenyi as adjuvant treatment following pancreatic cancer surgery.