Irinotecan hydrochloride trihydrate (Onivyde pegylated liposomal) was approved in March 2024 by the European Medicines Agency (EMA).

Indications:

• in combination with oxaliplatin, fluorouracil (5-FU) and leucovorin (LV) – NALIRIFOX – for the first-line treatment (is the one accepted as the best treatment) of adult patients with metastatic (the cancer has spread to other parts of the body) adenocarcinoma of the pancreas
• in combination with 5-FU and LV for the treatment of metastatic adenocarcinoma of the pancreas in adult patients who have gotten worse despite gemcitabine-based therapy.

NALIRIFOX is a chemotherapy treatment combining three approved pancreatic cancer drugs i.e.,  liposomal irinotecan (Onivyde) plus 5-FU/LV and oxaliplatin. All of the drugs in NALIRIFOX have already been approved for other purposes. What is new is the combination of these drugs together as a first-line treatment. This combination has now been approved for a new group of patients, those with metastatic pancreatic cancer who have not had any other treatment. This is the first approval for a first-line treatment for metastatic pancreatic cancer in over ten years.

References:

https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-onivyde-pegylated-liposomal-previously-known-onivyde-ii-34_en.pdf

https://www.ema.europa.eu/en/medicines/human/EPAR/onivyde-pegylated-liposomal-previously-known-onivyde

Z. A., Wainberg,…, E. M. O’Reilly. NALIRIFOX versus nab-paclitaxel and gemcitabine in treatment-naive patients with metastatic pancreatic ductal adenocarcinoma (NAPOLI 3): a randomised, open-label, phase 3 trial (2023). Lancet 2023; 402: 1272–81.

Author:
Ana Martins