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

Mary L Windle, PharmD

Disclosures

January 11, 2018

In This Article

Aliqopa (copanlisib)

Indication:

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

Mechanism:

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

Dosage:

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:

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.

Reference:

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.

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