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FDA Grants Priority Review to Copanlisib for Follicular Lymphoma

Jason M. Broderick @jasoncology
Published: Wednesday, May 17, 2017

The FDA has granted a priority review designation to copanlisib as a treatment for patients with relapsed/refractory follicular lymphoma who have received at 2 least prior therapies, according to Bayer, the manufacturer of the PI3K dual-isoform inhibitor.

The most common adverse events (all grades) were hyperglycemia (48.6%), hypertension (28.9%), and decreased neutrophil count (24.6%). Grade 3 hyperglycemia occurred in 33.1% of patients and grade 4 in 7.0%. Grade 3 hypertension occurred in 22.5%. Grade 3 decreased neutrophil count occurred in 6.3% and grade 4 in 12.7% of the patients. The most common laboratory abnormalities were elevated liver enzymes, which was grade 1/2 in all but a few cases.
Dreyling M, Santoro A, Mollica L, et al. Copanlisib in patients with relapsed or refractory indolent B-cell lymphoma: primary results of the pivotal CHRONOS-1 study. Presented at: 2017 AACR Annual Meeting; April 1-5, 2017; San Washington, DC. Abstract CT149.

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