FDA Grants Copanlisib Breakthrough Designation for MZL

May 30, 2019 – The FDA has granted copanlisib a breakthrough therapy designation for the treatment of adult patients with relapsed marginal zone lymphoma (MZL) who have received at least 2 prior therapies, according to Bayer, the manufacturer of the PI3K inhibitor. The designation, which will expedite the development and review of copanlisib in MZL, is based on data from the phase II CHRONOS-1 study. In a subgroup of 23 patients with MZL, the overall response rate … (leggi tutto)