Aliqopa FDA Approval History
Last updated by Judith Stewart, BPharm on Nov 15, 2023.
FDA Approved: Yes (Discontinued) (First approved September 14, 2017)
Brand name: Aliqopa
Generic name: copanlisib
Dosage form: Injection
Company: Bayer HealthCare Pharmaceuticals Inc.
Treatment for: Follicular Lymphoma
Aliqopa (copanlisib) is a phosphatidylinositol-3-kinase (PI3K) inhibitor indicated for the treatment of adult patients with relapsed follicular lymphoma (FL).
- On November 13, 2023, Bayer announced that, following discussions with the U.S. Food and Drug Administration (FDA), it would work with the FDA on a voluntary withdrawal of the Aliqopa (copanlisib) U.S. New Drug Application for adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies.
- Aliqopa was granted accelerated approval by the FDA in September 2017 based on CHRONOS-1, an open-label, single-arm Phase II study. The FDA required clinical benefit to be confirmed through the CHRONOS-4 study. In the study, the addition of Aliqopa to standard immunochemotherapy regimens did not meet the primary endpoint of progression-free survival benefit versus the standard immunochemotherapy control arm in patients with relapsed follicular lymphoma.
- Patients currently being treated with Aliqopa should consult their healthcare provider. No new patients should be prescribed Aliqopa.
Development timeline for Aliqopa
| Date | Article |
|---|---|
| Nov 13, 2023 | Bayer Provides Update on Voluntary Withdrawal of Aliqopa (copanlisib) |
| Sep 14, 2017 | Approval FDA Approves Aliqopa (copanlisib) for Adults with Relapsed Follicular Lymphoma |
Further information
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