Aliqopa Approved for Relapsed Follicular Lymphoma

The approval is based on data from a trial of 104 patients with follicular B-cell non-Hodgkin lymphoma
The approval is based on data from a trial of 104 patients with follicular B-cell non-Hodgkin lymphoma

Aliqopa (copanlisib; Bayer) intravenous injection has been granted accelerated approval by the Food and Drug Administration (FDA) to treat adults with relapsed follicular lymphoma who have received at least 2 prior systemic therapies.

Aliqopa is a kinase inhibitor that blocks several enzymes involved in cell growth. The accelerated approval was based on data from a single-arm trial of 104 patients with follicular B-cell non-Hodgkin lymphoma who had relapsed after ≥2 prior treatments. The study evaluated the number of patients experiencing partial or complete shrinkage of their tumors after treatment. Results showed that 59% of patients had a complete or partial response for a median 12.2 months.  

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Further clinical trials to confirm Aliqopa's clinical benefit are currently ongoing. Serious side effects of Aliqopa include infections, hyperglycemia, hypertension, non-infectious pneumonitis, neutropenia, and severe skin reactions.

Aliqopa was previously granted Priority Review and Orphan Drug designation by the FDA. It will be available as a 60mg lyophilized solid for reconstitution in single-dose vials.

For more information visit FDA.gov.