Press Release

Ipsen receives FDA Fast Track designation for liposomal irinotecan (ONIVYDE®) as a first-line combination treatment for metastatic pancreatic cancer

– Final analysis of the Phase 1/2 clinical study to be presented as a late-breaking virtual presentation at the ESMO World Congress on Gastrointestinal Cancer (WCGI) on July 1, 2020 –


Paris (France), 17 June 2020 –Ipsen (Euronext: IPN; ADR: IPSEY) today announced the United States Food and Drug Administration (FDA) has granted the company 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). The FDA’s Fast Track program facilitates the development and expedites the review of drugs that treat serious conditions and have the potential to address an unmet medical need.

The final analysis from the multicenter, open-label Phase 1/2 study will be presented as a late-breaking oral presentation at the first time ever virtual ESMO World Congress on Gastrointestinal Cancer on July 1, 2020 and will include data on primary and secondary endpoints. Ipsen has also initiated patient enrollment in the international Phase 3 NAPOLI-3 clinical study investigating the safety and efficacy of NALIRIFOX versus gemcitabine + nab-paclitaxel in the first-line setting (NCT04083235).

ONIVYDE® is approved in the United States and in Europe in combination with fluorouracil (5-FU) and leucovorin (LV) for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. ONIVYDE® is not indicated as a single agent for the treatment of patients with metastatic adenocarcinoma of the pancreas.

“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, M.D., Executive Vice President, Head of Research and Development at Ipsen. “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.”

Pancreatic cancer is a rare and deadly disease that accounts for about 3% of all cancer and 7% of all cancer deaths.1 Of the 57,600 people with pancreatic cancer in the United States, more than half are diagnosed with metastatic disease, which has an overall 5-year survival rate of three percent (3%).1

Programs with Fast Track designation may benefit from early and frequent interactions with the FDA over the course of drug development. In addition, the Fast Track designation program allows for the eligibility for accelerated approval and priority review if relevant study criteria are met and enables a company to submit individual sections of a New Drug Application (NDA) for review on a rolling-submission basis.

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