Parsaclisib new drug application withdrawn for relapsed/refractory MCL, MZL, and FL

On January 25, 2022, the new drug application for parsaclisib to treat relapsed/refractory mantle cell lymphoma, marginal zone lymphoma, and follicular lymphoma was withdrawn.¹ The decision was made following discourse with the U.S. Food and Drug Administration (FDA) about the need for confirmatory studies in support of an accelerated approval, as the research would not be completed within the required time frame. The manufacturing company highlighted that the safety and efficacy of parsaclisib has not changed, and the withdrawal was a business-related decision affecting only US-based clinical trials.

Parsaclisib was most recently assessed as part of the phase II CITADEL-205 trial (NCT03235544) in a population of patients with relapsed/refractory mantle cell lymphoma who had not previously undergone treatment with a Bruton’s tyrosine kinase inhibitor.

About parsaclisib

Parsaclisib is a potent, highly selective, next-generation investigational novel oral inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ). The agent is currently under evaluation as a monotherapy in several ongoing phase II trials as a treatment for non-Hodgkin lymphomas.