Bayer’s lymphoma treatment gains FDA Breakthrough Therapy Designation
FDA has given Breakthrough Therapy Designation to Bayer’s PI3K inhibitor Copanlisib for marginal zone lymphoma (MZL) patients who have received two prior therapies. MZL is an indolent form of non-Hodgkin’s Lymphoma (iNHL) and accounts for approximately 10% of all non-Hodgkin’s Lymphoma cases in the US. The designation was based on data from a MZL subgroup