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# Incyte Pulling Parsaclisib NDA
- URL: https://www.fdaweb.com/incyte-pulling-parsaclisib-nda/
- Published: 2022-01-26T12:00:00.000Z
- Updated: 2026-09-14T17:30:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151009

Incyte says that after discussions with FDA, it has made a business decision to withdraw its NDA for parsaclisib to treat patients with relapsed or refractory follicular lymphoma, marginal zone lymphoma, and mantle cell lymphoma. The company [says](https://investor.incyte.com/press-releases/press-releases/2022/Incyte-Provides-Update-on-Parsaclisib-and-MCLA-145/default.aspx?ref=fdaweb.com) its decision followed discussions with FDA about confirmatory studies needed to support an accelerated approval. Incyte says it determined the studies could not be completed within a period that would support the investment. It says the withdrawal of the NDA is not related to any changes in the drug’s safety or efficacy.

Parsaclisib is described as a potent, highly selective, next-generation investigational novel oral inhibitor of phosphatidylinositol 3-kinase delta. It is currently under evaluation as a monotherapy in Phase 2 trials to treat non-Hodgkin lymphomas and in a Phase 3 study for autoimmune hemolytic anemia, Incyte says. The company says pivotal trials of parsaclisib in combination with ruxolitinib to treat patients with myelofibrosis also are underway.