The FDA awarded Bayer's Aliqopa a breakthrough treatment designation

the U.S. Food and Drug Administration (FDA) has awarded Bayer THE PI3K inhibitor Aliqopa (copanlisib) a breakthrough treatment designation.company said the decision was based on follow-up data from the key Phase II study CHRONOS-1, which showed the drug's efficacy in patients with inert non-Hodgkin's lymphoma (iNHL).is intended for patients who have been treated at least twice, including patients with relapsed or incurable marginal lymphoma (MZL).the company is conducting two other Phase III studies - CHRONOS-3 and CHRONOS-4 - to confirm the effectiveness and safety of aliqopa and other therapies that relapse after one or more previous treatments in patients with iNHL, including MZL."Clinical evidence suggests that copanlisib can address unsealed medical needs by providing doctors and MZL patients with treatment in a recurrence environment that is not approved," said Dr. Scott Fields, senior vice president and head of oncology development at Bayer Pharmaceuticals. Thehas not yet been approved by the European Medicines Agency (EMA) or other agencies outside the United States.The FDA's breakthrough treatment designations are designed to accelerate the development and review of drug candidates for treatment of serious or life-threatening diseases or conditions, with special results in early trials.MZL adaptation is an inert form of non-Hodgkin's lymphoma (iNHL), accounting for about 10 percent of all non-Hodgkin's lymphoma in the United States. (Compiled by this web)