Merrimack Reports Ipsen Announcement of Approval By The US FDA of Onivyde® (Irinotecan Liposome Injection) Plus 5 Fluorouracil/Leucovorin and Oxaliplatin (NALIRIFOX) as a First-Line Treatment for Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)
Supplemental New Drug Application (sNDA) submission based on the NAPOLI 3 Phase III trial1Approval would represent expansion of treatment options in an aggressive and difficult-to-treat cancer with...
Ipsen will seek a new approval for Onivyde (irinotecan liposome injection) as a treatment for metastatic pancreatic ductal adenocarcinoma (mPDAC) after posting positive Phase III progression survival data.
Onivyde® Regimen Demonstrated Statistically Significant Improvement in Overall Survival in Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma
Ipsen and Servier’s hopes of extending the uses for chemotherapy drug Onivyde have been knocked back by a failed phase 3 trial of the drug as a second-line therapy for small cell lung cancer (SCLC).
Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the Phase III RESILIENT trial did not meet its primary endpoint of overall survival (OS) compared to topotecan. The trial is evaluating Onivyde® (irinotecan liposomal injection) versus topotecan in patients with small cell lung cancer (SCLC), who have progressed on or after platinum-based first-line therapy treatment. RESILIENT is a Phase III trial conducted in two parts; the first part read out in 2020 confirming the safety, dosing and efficacy of Onivyde; part two is evaluating the efficacy of Onivyde versus topotecan. Detailed results from the RESILIENT trial will be presented at an upcoming medical conference.
This is an anticancer drug called irinotecan that's been used to treat colon cancer. It gets injected into a patient in an inactive form, before becoming active within the patient's body. This action not only makes the drug less efficient, but it also has risks of side effects.