Incyte's Parsaclisib Application Under FDA Review For 3 Types Of Non-Hodgkin Lymphomas

The FDA has accepted for review Incyte Corporation's INCY marketing application for parsaclisib for relapsed or refractory follicular lymphoma (FL), marginal zone lymphoma (MZL), and mantle cell lymphoma (MCL).
Parsaclisib is an investigational novel potent, highly selective, next-generation oral inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ).
The submission is based on data from several Phase 2 studies, wherein Parsaclisib was generally well-tolerated with a manageable safety profile.
The FDA has granted Parsaclisib Priority Review for relapsed or refractory MZL who have received at least one prior anti-CD20-based regimen and MCL who have received at least one prior therapy.
The Prescription Drug User Fee Act (PDUFA) target action date for these indications is April 30, 2022.
The application for relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies has a PDUFA target action date of August 30, 2022.
Confirmatory phase 3 studies are in preparation for parsaclisib.
Related content: Benzinga's Full FDA Calendar.
Price Action: INCY shares closed up 3.94% at $69.35 on Monday.