FDA Grants Bayer Priority Review for Copanlisib in Follicular Lymphoma

The FDA granted priority review to Bayer’s copanlisib for the treatment of relapsed or refractory follicular lymphoma patients who have received at least two prior therapies.

This decision is based on data from a Phase II clinical study evaluating patients with relapsed or refractory indolent non-Hodgkin’s lymphoma. Bayer is seeking accelerated approval. The compound was also granted Fast Track and Orphan Drug designations by the FDA in this indication.

Copanlisib has also been granted an Orphan Drug designation for the treatment of splenic, nodal and extranodal subtypes of marginal zone lymphoma.