Copanlisib Receives Accelerated Approval for Relapsed Follicular Lymphoma

Patients with relapsed follicular lymphoma now have a new treatment option: copanlisib, a kinase inhibitor that was recently approved through the FDA’s accelerated approval process.

The approval was announced by the FDA in a statement that explained how the limited treatment options for this type of follicular lymphoma paved the way for the accelerated approval of copanlisib, which will be marketed by Bayer as Aliqopa.

Follicular lymphoma is a type of non-Hodgkin lymphoma, and the drug is specifically indicated for adults with follicular lymphoma that has relapsed after at least 2 prior lines of systemic therapies. Copanlisib is “a kinase inhibitor that works by blocking several enzymes that promote cell growth,” according to the FDA statement.

The approval was based on results from a trial of 104 patients with relapsed follicular lymphoma. It found that 59% of patients demonstrated a complete or partial response to the therapy for a median 12.2 months as measured by tumor shrinkage, although the study did not include a placebo arm.

More extensive studies are being carried out by Bayer in hopes of confirming the clinical benefit of copanlisib. In the meantime, the accelerated approval indicates the FDA’s recognition that there is unmet clinical need among patients with the indicated disease, and that early data predicts the new therapy could be beneficial for patients in need.

“For patients with relapsed follicular lymphoma, the cancer often comes back even after multiple treatments,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in the announcement. “Options are limited for these patients and today’s approval provides an additional choice for treatment, filling an unmet need for them.”

The FDA has also granted priority review status and orphan drug designation to copanlisib, reflecting the rare and serious nature of the disease it is intended to treat.

"Before the approval of Aliqopa, doctors and patients facing follicular lymphoma, a very serious and difficult-to-treat blood cancer, have had a need for new and effective options when patients relapse," said Carsten Brunn, Head of Bayer Pharmaceuticals, Americas Region, in a press statement from Bayer.

"The FDA's accelerated approval of this important treatment reflects Bayer's commitment to delivering new treatment options, and we commend the FDA on its speedy review and ongoing dedication to innovation in areas of great unmet medical need."