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Incyte provides update on parsaclisib and MCLA-145.

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Published:27th Jan 2022
Incyte has announced updates regarding the clinical development of parsaclisib, the Company’s next-generation oral inhibitor of phosphatidylinositol 3-kinase delta (PI3K?), and MCLA-145, its CD137/PD-L1 bispecific antibody co-developed under a global collaboration and license agreement with Merus.

Incyte is withdrawing the New Drug Application (NDA) for parsaclisib for the treatment of patients with relapsed or refractory follicular lymphoma (FL), marginal zone lymphoma (MZL) and mantle cell lymphoma (MCL). The decision to withdraw the NDA follows discussions with FDA regarding confirmatory studies to support an accelerated approval, which Incyte determined cannot be completed within a time period that would support the investment. The withdrawal of the NDA is a business decision and is not related to any changes in either the efficacy or safety of parsaclisib. The decision impacts only the FL, MZL and MCL indications in the U.S., and does not affect other ongoing clinical trials in the U.S. or other countries. Additionally, as part of its ongoing portfolio prioritization and capital allocation review, Incyte has decided to opt-out of the continued development of MCLA-145. Incyte will continue to collaborate with Merus and leverage their platform to develop a pipeline of novel agents.

Condition: Mantle Cell Lymphoma
Type: drug

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