Drug intelligence / Profile preview

NALIRIFOX

Development stage
Phase 2
Lead developer
Ipsen
Modality
Small Molecules
Administration
Intravenous
01

Overview

NALIRIFOX is a chemotherapy regimen used as a first-line treatment for metastatic pancreatic adenocarcinoma. It consists of four drugs administered together: - Liposomal irinotecan (Onivyde), a topoisomerase I inhibitor encapsulated in liposomes to prolong circulation and enhance tumor delivery. - Oxaliplatin, a platinum-based alkylating agent that forms DNA cross-links. - Fluorouracil (5-FU), an antimetabolite that disrupts DNA synthesis. - Leucovorin (folinic acid), which enhances the effects of 5-FU and protects healthy cells. The key distinction between NALIRIFOX and the similar FOLFIRINOX regimen is the use of liposomal irinotecan instead of standard irinotecan, resulting in improved pharmacokinetics and potentially reduced toxicity. The combination was approved by the FDA in February 2024 and by EMA in March 2024 for first-line treatment of metastatic pancreatic cancer. Clinical trials demonstrated improved overall survival compared to gemcitabine plus nab-paclitaxel[1][2][3][4][5][7].

Brand names
Onivyde
Other names
FOLFOXIRINALIRIFOX
02

Targets

TOP1 (DNA Topoisomerase I)DNATS (Thymidylate synthase)

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