(Reuters) - The U.S. Food and Drug Administration said on Thursday it has approved Bayer AG’s treatment for follicular lymphoma, a cancer of the lymph system.
The drug, Aliqopa, known also as copanlisib, is a kinase inhibitor that blocks certain enzymes that promote cell growth. It is designed for patients who have received at least two prior treatments.
Follicular lymphoma is a slow-growing type of non-Hodgkin lymphoma. An estimated 72,240 people in the United States will be diagnosed with some form of non-Hodgkin lymphoma this year.
The FDA granted Aliqopa accelerated approval, meaning clinical data suggests it will be beneficial, but further trials will be needed to prove that. In a trial of 104 patients, 59 percent experienced a complete or partial shrinkage of their tumors for a median 12.2 months.
Reporting by Toni Clarke in Washington; Editing by Matthew Lewis