The FDA grants copanlisib Priority Review for the possible treatment of relapsed/refractory Follicular Lymphoma

On 17th May 2017, copanlisib (BAY 80-6946), a pan-class I PI3K inhibitor, was granted Priority Review by the U.S. Food and Drug Administration (FDA) for the treatment of R/R FL patients who have received ≥2 previous treatments.

This regulatory submission was based on results of the pivotal CHRONOS-1 phase II trial, which aimed to assess the safety and efficacy of copanlisib in 141 patients with R/R iNHL. Primary results for the whole patient cohort were presented at this year’s American Association for Cancer Research (AACR) annual meeting, which the Lymphoma Hub reported on last month. Data specifically from patients with FL will be presented at this year’s American Society of Clinical Oncology (ASCO) annual meeting in June.

Bayer’s copanlisib has already been awarded Fast Track and Orphan Drug designations by the FDA for R/R FL.

  1. Healio. FDA grants priority review to copanlisib for follicular lymphoma. 2017 May 17. http://www.healio.com/hematology-oncology/lymphoma/news/online/%7B57a7aaf4-5367-41b9-b26b-027f72907b03%7D/fda-grants-priority-review-to-copanlisib-for-follicular-lymphoma. [Accessed 2017 May 18].