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# FDA Accepts NDA for Parsaclisib in Lymphomas
- URL: https://www.fdaweb.com/fda-accepts-nda-for-parsaclisib-in-lymphomas/
- Published: 2021-11-02T12:00:00.000Z
- Updated: 2026-09-14T17:21:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150500

FDA has accepted for review an Incyte NDA seeking approval of parsaclisib for treating patients with relapsed or refractory follicular lymphoma, marginal zone lymphoma (MZL) and mantle cell lymphoma (MCL). The submission is based on data from three Phase 2 studies (CITADEL-203, -204 and -205) evaluating parsaclisib as a treatment for relapsed or refractory NHLs (follicular, marginal zone and mantle cell).

A priority review was granted for the indications for treating adult patients with relapsed or refractory MZL who have received at least one prior anti-CD20-based regimen and for patients with MCL who have received at least one prior therapy; the user fee review action target date is 4/30/2022\. The indication for parsaclisib in adult patients with relapsed or refractory follicular lymphoma who have received at least two prior systemic therapies will see a standard review and review action target date of 8/30/2022.