Investigational Irinotecan Liposome Injection Granted FDA Fast Track Designation

The United States Food and Drug Administration (FDA) has granted Fast Track designation for irinotecan liposome injection (ONIVYDE®) in study patients with small cell lung cancer (SCLC) who progressed following a first-line platinum-based regimen, reflecting the unmet medical need.

Announced by Paris-based Ipsen on November 30, 2020, ONIVYDE is currently 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.

An ongoing Phase III randomized study trial is being conducted to assess the efficacy and safety of investigational irinotecan liposome injection (ONIVYDE) as a monotherapy for SCLC study patients who have progressed on or after a first-line platinum-based regimen.

“The Fast Track designation of ONIVYDE® as a potential treatment for people living with small cell lung cancer is an extension of Ipsen’s focus and contribution to the treatment landscape in oncology,” said Howard Mayer, M.D., Executive Vice President, Head of Research and Development at Ipsen, in a press release. “With this aggressive and often late-stage diagnosed form of lung cancer, we are proud to be one step closer to making another treatment option available to patients.”

In 2020, the American Cancer Society estimates there to be about 228,280 new cases of lung cancer in the US (116,300 in men and 112,520 in women). 

And SCLC comprises up to 15 percent of all lung cancers and is a very aggressive form of cancer with about 70 percent of people having metastatic disease when they are diagnosed.

ONIVYDE also received FDA Fast Track designation in June 2020 for first-line irinotecan liposome injection in combination with 5- fluorouracil/leucovorin and oxaliplatin together, known as NALIRIFOX for study patients with previously untreated, unresectable, locally advanced and metastatic pancreatic ductal adenocarcinoma. 

An ongoing Phase 3 randomized study is being conducted to assess the efficacy and safety of NALIRIFOX in study patients who are not previously treated for metastatic pancreatic cancer.

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 for review on a rolling submission basis.

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