The FDA has granted approval to a new medicine for patients with aggressive, metastatic pancreatic adenocarcinoma. The agency began its priority review of the drug following positive phase 3 trial results.
Made by Paris-based drugmaker Ipsen, the new therapy, irinotecan liposome, known by its brand name Onivyde, is an injection that the FDA now recommends being administered through infusion every two weeks. The infusion process takes about 90 minutes total.
During the phase 3 trial, which included 770 patients, Onivyde extended longevity for patients who took it regularly by a median survival length of 11.1 months versus just 9.2 months of survival for patients who received other treatments.
Adverse outcomes were rare and the most common side effects for patients involved in the trial were fatigue, nausea, vomiting, decreased appetite, abdominal pain and diarrhea.
Onivyde was designated by the FDA to be an "orphan drug", which is not necessarily profitable, but a drug created for treatment of patients with rare conditions.