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Ipsen scores FDA fast-track for Onivyde in first-line pancreatic cancer

Treatment could meet unmet need in rare cancer type


French pharma company Ipsen has been granted a fast-track designation by the US Food and Drug Administration (FDA) for its immunotherapy treatment Onivyde in previously untreated pancreatic cancer.

The FDA designation will review the use of Onivyde (liposomal irinotecan) in combination with 5- fluorouracil/leucovorin (5-FU/LV) and oxaliplatin (OX), also known as Nalirifox, in patients with previously untreated, unresectable, locally advanced and metastatic pancreatic ductal adenocarcinoma (PDAC).

The fast-track programme aids the development and also expedites the review of drugs that are designed to treat serious medical conditions and have the potential to address an unmet medical need.

Pancreatic cancer is a rare type of cancer and carries a poor prognosis in the majority of cases. Of the 57,600 people with pancreatic cancer in the US, over half are diagnosed with metastatic disease, which carries an overall five-year survival rate of just 3%.

Ipsen has yet to unveil the data from its phase 1/2 study of Onivyde, although it is due to reveal the full results at the upcoming virtual ESMO World Congress on Gastrointestinal Cancer on 1 July. However, with Ipsen having already initiated a phase 3 study of the treatment, NAPOLI-3, it is safe to presume that results from the phase 1/2 trial will be encouraging and warrant further study.

Onivyde is already approved in the US and Europe in combination with 5-FU/LV for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy.

“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,” said Howard Mayer, executive vice president, head of research and development at Ipsen.

“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.

“As we continue to enrol 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,” he added.

Article by

19th June 2020

From: Research, Regulatory



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