Incyte has decided to withdraw the New Drug Application (NDA) for parsaclisib for the treatment of relapsed or refractory follicular lymphoma (FL), marginal zone lymphoma (MZL) and mantle cell lymphoma (MCL).
Parsaclisib is an investigational oral inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ). In November 2021, the Food and Drug Administration (FDA) accepted for review the NDA for parsaclisib for the treatment of patients with relapsed or refractory FL, MZL, and MCL. The application included data from several phase 2 studies (ClinicalTrials.gov Identifier: NCT03126019, NCT03144674, NCT03235544).
The decision to withdraw the application was made after the Company determined that confirmatory studies to support an accelerated approval for parsaclisib could not be completed within a time period which would support the investment. The Company noted that the “withdrawal of the NDA is a business decision and is not related to any changes in either efficacy or safety of parsaclisib.”
This decision only affects the FL, MZL, and MCL indications for parsaclisib in the US and does not affect other ongoing clinical trials in the US or other countries. Parsaclisib is currently being evaluated as monotherapy for the treatment of autoimmune hemolytic anemia (ClinicalTrials.gov Identifier: NCT05073458) and in combination with ruxolitinib for the treatment of myelofibrosis (ClinicalTrials.gov Identifier: NCT04551066).
Incyte provides update on Parsaclisib and MCLA-145. News release. Incyte. Accessed January 26, 2022. https://www.businesswire.com/news/home/20220125006021/en/Incyte-Provides-Update-on-Parsaclisib-and-MCLA-145