Onivyde pegylated liposomal

Onivyde pegylated liposomal is indicated in combination with oxaliplatin, 5-fluorouracil (5-FU), and leucovorin (LV) for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas. The drug received Orphan medicinal product designation on 09 December 2011 and its application for regulatory review was submitted on 30 April 2015. The CHMP Opinion date was 21 March 2024.

In efficacy studies, the median Overall Survival (OS) for MM-398 + 5-FU/LV was 6.1 months, compared to 4.2 months for 5-FU/LV, with a Hazard Ratio of 0.67 (p-value 0.0122). The median Progression-Free Survival (PFS) for MM-398 + 5-FU/LV was 3.1 months, compared to 1.6 months for 5-FU/LV. An OS advantage of 2.6 months was observed for the OFF regimen versus control in patients with disease progression after first-line gemcitabine.

Safety findings include an approximate lethal dose of 200 mg/kg for MM-398 and a maximum tolerated dose of 15 mg/kg bw. The margin between MM-398 mortality and the human therapeutic dose is 14-19x. Lower thymus weights (32-80%) and lower liver weights (6-24%) were observed with MM-398. The margin between the LOAEL and human therapeutic dose for liver effects is 2x.