US FDA approves treatment for pancreatic cancer

Irinotecan liposome injection, administered in combination with fluorouracil (5FU) and leucovorin (LV), is beneficial for the treatment of patients with metastatic adenocarcinoma of the pancreas whose disease has progressed following gemcitabine-based therapy

The US Food and Drug Administration (US FDA) has approved irinotecan liposome injection, administered in combination with fluorouracil (5FU) and leucovorin (LV), for the treatment of patients with metastatic adenocarcinoma of the pancreas whose disease has progressed following gemcitabine-based therapy. Irinotecan liposome is not approved for use as a single agent for the treatment of patients with metastatic adenocarcinoma of the pancreas.

The approval was based on the demonstration of improved overall survival (OS) in a multi-centre, randomised, open-label, active-controlled, three-arm trial enrolling 417 patients with metastatic pancreatic adenocarcinoma with documented disease progression after gemcitabine-based therapy.