The New Drug Application (NDA) for copanlisib (Bayer) has been granted Priority Review by the Food and Drug Administration (FDA). Copanlisib is an investigational treatment for patients with relapsed or refractory follicular lymphoma who have received at least two prior treatments.

Copanlisib is a pan-Class I phosphatidylinositol-3-kinase (PI3K) inhibitor. The NDA submission was based on the Phase 2 trial, ‘Chronos-1′ which included 141 patients with indolent non-Hodgkin’s lymphoma (iNHL). The primary endpoint of  the study was objective tumor response rate, with duration of response, overall survival, progression-free survival, quality of life, and safety serving as secondary endpoints. The full findings were presented at the American Association for Cancer Research’s Annual Meeting. 

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Bayer is planning to request Accelerated Approval for copanlisib. The company is currently enrolling patients for two Phase 3 trials (Chronos-3 and Chronos-4) to further investigate the efficacy and safety of copanlisib.

Orphan designation has also been granted to copanlisib for the treatment of splenic, nodal, and extranoldal subtypes of marginal zone lymphoma. 

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