FDA New Drug and Biologic Approvals -- 2017 Year-in-Review

Mary L Windle, PharmD


January 11, 2018

In This Article

Aliqopa (copanlisib)


Patients with relapsed follicular lymphoma (FL) who have received at least 2 prior systemic therapies.


Pan class I phosphatidylinositol-3-kinase (PI3K) inhibitor with predominant inhibitory activity against PI3K-alpha and PI3K-delta isoforms expressed in malignant B cells.


60 mg IV on days 1, 8, and 15 of a 28-day treatment cycle on an intermittent schedule (21 days on and 7 days off). Continue treatment until disease progression or unacceptable toxicity.


Approval was based primarily on results of the phase 2 CHRONOS-1 trial. In CHRONOS-1, patients received copanlisib at 60 mg IV on days 1, 8, and 15, repeated every 28 days until disease progression or development of unacceptable toxicity. Overall response rate was 59.2% (12.0% complete and 47.2% partial). An additional 29.6% of patients had stable disease, resulting in a disease control rate of 85.9%. Median progression-free survival for patients with all disease types, including follicular lymphoma, was 11.2 months.


Dreyling M, et al. Copanlisib in patients with relapsed or refractory indolent B-cell lymphoma: primary results of the pivotal CHRONOS-1 study. Hematology Oncology. June 7, 2017.


Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.