FDA grants fast track designation for advanced pancreatic cancer treatment
The U.S. Food and Drug Administration (FDA) has granted fast track designation for the investigational use of liposomal irinotecan (Onivyde) in combination with 5- fluorouracil/leucovorin (5-FU/LV) and oxaliplatin (OX) together, known as NALIRIFOX for patients with previously untreated, unresectable, locally advanced and metastatic pancreatic ductal adenocarcinoma (PDAC).
“Since the initial approval of Onivyde in metastatic pancreatic cancer, we have continued to dedicate our research efforts to better understand the needs of pancreatic cancer patients. Through ongoing clinical investigations and exploratory real-world analyses, we have sought to determine whether patients who receive active treatment early have an improvement in survival,” said Howard Mayer, MD, Executive Vice President, Head of Research and Development at Ipsen in a press release. “As we continue to enroll additional patients in the ongoing Phase 3 NAPOLI-3 clinical study, we look forward to working closely with the FDA to potentially bring Onivyde to more pancreatic cancer patients earlier in the disease.”
Data from the Phase 1/2 clinical study will be presented at the ESMO World Congress on Gastrointestinal Cancer on July 1, 2020.
Read the full press release here.