ONIVYDE is currently approved in
An ongoing Phase III randomized study (RESILIENT; NCT03088813) 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
Lung cancer is the second most common cancer in
ONIVYDE also received Fast Track designation in
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.
ABOUT ONIVYDE (irinotecan liposome injection)
Ipsen has exclusive commercialization rights for the current and potential future indications for ONIVYDE in the
About Ipsen
Ipsen is a global specialty-driven biopharmaceutical group focused on innovation and Specialty Care. The Group develops and commercializes innovative medicines in three key therapeutic areas - Oncology, Neuroscience, and Rare Diseases. Ipsen also has a well-established
Ipsen's Forward Looking Statement
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