FDA Grants Fast Track Designation to Irinotecan Liposome Injection for Second-Line Treatment of SCLC

December 1, 2020
Kristie L. Kahl

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The agency granted fast track designation to irinotecan liposome injection for patients with small cell lung cancer who progressed following a first-line platinum-based regimen.

The FDA granted fast track designation to irinotecan liposome injection (Onivyde) for the treatment of patients with small cell lung cancer (SCLC) who progressed following a first-line platinum-based regimen, according to Ipsen, the agent’s manufacturer.

“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,” Howard Mayer, MD, executive vice president and head of research and development at Ipsen, said in a press releasee. “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.”

The agent is being evaluated in the ongoing, randomized phase 3 RESILIENT trial (NCT03088813), designed to evaluate the efficacy and safety of irinotecan liposome injection as a monotherapy for patients with SCLC who have progressed on or after a first-line platinum-based regimen.

Irinotecan is currently FDA approved in combination with fluorouracil (5-FU) and leucovorin for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. In addition, the agent also received fast track designation in June, in combination with 5-FU, leucovorin, and oxaliplatin – also known as NALIRIFOX – for the first-line treatment of patients with previously untreated, unresectable, locally advanced and metastatic pancreatic ductal adenocarcinoma. The ongoing, randomized phase 3 NAPOLI-3 study (NCT04083235) is being conducted to assess the efficacy and safety of NALIRIFOX in patients who are not previously treated for metastatic pancreatic cancer.

Reference:

Ipsen. Ipsen receives FDA Fast Track designation for investigational irinotecan liposome injection (ONIVYDE®) as a second-line monotherapy treatment for small cell lung cancer (SCLC). Published: December 1, 2020. https://www.ipsen.com/press-releases/ipsen-receives-fda-fast-track-designation-for-investigational-irinotecan-liposome-injection-onivyde-as-a-second-line-monotherapy-treatment-for-small-cell-lung-cancer-sclc/. Accessed: December 1, 2020.