Hengrui Medicine irinotecan hydrochloride liposome injection for the treatment of advanced pancreatic cancer

Article source: Medical Cube Info

On April 20, Hengrui announced that it had submitted a marketing application for irinotecan hydrochloride liposome injection to the Food and Drug Administration, in combination with 5-FU/LV second-line treatment of locally advanced or metastatic pancreatic cancer after failure of gemcitabine therapy

Pancreatic cancer has a very high degree of malignancy and poor prognosis.

The specific etiology and pathogenesis of pancreatic cancer are not yet clear, and most of them are adenocarcinomas originating from the ductal epithelium

Severe delayed diarrhea and neutropenia have been observed in the clinical application of common preparations of irinotecan hydrochloride

The marketing application is based on the data of the Phase III study of irinotecan hydrochloride liposome combined with 5-FU/LV in the treatment of pancreatic cancer (HR-IRI-APC).

HR-IRI-APC is a randomized, double-blind, placebo-controlled, multicenter Phase III study to evaluate irinotecan hydrochloride liposomal injection combined with 5-FU/LV for unresectable failure of gemcitabine therapy efficacy and safety in patients with locally advanced or metastatic pancreatic cancer

A total of 298 subjects were enrolled in the study and randomly assigned to the experimental group and the control group (149 cases in each) according to 1:1, and received irinotecan hydrochloride liposome combined with 5-FU/LV once every 2 weeks.

The results show that irinotecan hydrochloride liposome injection combined with 5-FU/LV can significantly prolong the overall survival (OS) of patients compared with placebo combined with 5-FU/LV