FDA grants fast track designation to Onivyde for advanced pancreatic cancer
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The FDA granted fast track designation to liposomal irinotecan as part of a first-line combination for the treatment of adults with previously untreated, unresectable, locally advanced and metastatic pancreatic ductal adenocarcinoma.
This indication applies to the use of liposomal irinotecan (Onivyde, Ipsen) — a liposomal formulation of the topoisomerase I inhibitor irinotecan — in combination with 5-FU/leucovorin and oxaliplatin, known as NALIRIFOX, according to a manufacturer-issued press release.
Liposomal irinotecan previously received FDA approval for use with 5-FU and leucovorin for metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy.
Data from a multicenter, open-label phase 1/phase 2 study that supported the fast track designation will be presented as a late-breaking oral presentation at the virtual ESMO World Congress on Gastrointestinal Cancer in July. NALIRIFOX also is under investigation in the phase 3 NAPOLI-3 trial compared with gemcitabine and nab-paclitaxel in the first-line setting.
“Since the initial approval of Onivyde in metastatic pancreatic cancer, we have continued to dedicate our research efforts to better understand the needs of [patients with pancreatic cancer]. 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,” Howard Mayer, MD, executive vice president and head of research and development at Ipsen, said in the 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 [patients with pancreatic cancer] earlier in the disease.”
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