(CercleFinance.com) – Ipsen announces that the United States FDA has accepted its application for an additional indication for its Onivyde in combination, as a potential first-line treatment in patients with metastatic pancreatic ductal adenocarcinoma.
This decision is based on the pivotal phase III NAPOLI 3 trial, which demonstrated a statistically significant improvement in overall survival and progression-free survival, with a safety profile consistent with that of the treatment components.
The FDA has set February 13, 2024 as the expected date for its decision. Approval would expand treatment options for an aggressive and difficult-to-treat cancer for which few treatment options are currently available.