Benzinga | Nov 2, 2021 10:37AM EDT

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

* The FDA has accepted for review Incyte Corporation's (NASDAQ: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 (PI3K?).

* 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.