Posted by Michael Wonder on 01 Dec 2020
Ipsen receives FDA fast track designation for investigational irinotecan liposome injection (Onivyde) as a second-line monotherapy treatment for small cell lung cancer
30 November 2020 - Ipsen today announced the United States FDA has granted the company fast track designation for irinotecan liposome injection (Onivyde) in study patients with small cell lung cancer who progressed following a first-line platinum-based regimen, reflecting the unmet medical need.
An ongoing Phase 3 randomised trial is being conducted to assess the efficacy and safety of investigational irinotecan liposome injection (Onivyde) as a monotherapy for small cell lung cancer study patients who have progressed on or after a first-line platinum-based regimen.
