WASHINGTON -- The FDA announced Thursday that it approved a for adults with relapsed follicular lymphoma who have received at least two prior systemic therapies.
Copanlisib is a pan-Class I phosphatidylinositol-3-kinase (PI3K) inhibitor with predominant inhibitory activity against PI3K-α and PI3K-δ isoforms, according to drugmaker Bayer Healthcare.
"Options are limited for [relapsed] patients and today's approval provides an additional choice for treatment, filling an unmet need for them," said Richard Pazdur, MD, acting director of the Office of Hematology and Oncology Products in the FDA's drugs division.
Approval of copanlisib was based primarily on an open-label trial enrolling 104 patients with follicular non-Hodgkin B-cell lymphoma, in which 59% obtained complete or partial responses with median duration of 12.2 months.
The drug comes with a range of adverse effects. Serious potential toxicities include hyperglycemia, hypertension, pneumonitis, neutropenia, and skin reactions. The drug may induce fetal abnormalities and should not be taken by pregnant or breastfeeding women.
Bayer had received priority review, orphan drug, and accelerated approval designations from the FDA. The latter requires the firm to conduct additional studies to confirm copanlisib's clinical benefit. Such studies are now underway, the agency said.