(Boursier.com) — Ipsen indicates that the US authorities (Food and Drug Administration, FDA) have accepted its application for additional indication of Onivyde (liposomal irinotecan for injection) in combination with 5-fluorouracil/leucovorin and oxaliplatin (NALIRIFOX regimen) as a potential treatment for first line in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC).
This decision is based on the positive results of the pivotal Phase III NAPOLI 3 trial, in which the Onivyde treatment regimen demonstrated a statistically significant improvement in overall survival (OS) and progression-free survival (PFS), compared to nab-paclitaxel in combination with gemcitabine, with a safety profile consistent with that of the treatment components.
Approval of this treatment regimen would expand treatment options for an aggressive and difficult-to-treat cancer, for which few treatment options are currently available
These results were presented in January 2023 at the American Society of Clinical Oncology (ASCO GI) Symposium on Gastrointestinal Cancers.
Recall that in 2020, the FDA granted Ipsen “Fast Track” designation for Onivyde as a first-line combination treatment in mPDAC. The FDA’s “Fast Track” program is intended to facilitate the development and expedite the review of drugs that target serious conditions and have the potential to address an unmet medical need.
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