• US FDA grants breakthrough therapy designation to Bayer’s copanlisib to treat marginal zone lymphoma

    • May 30, 2019
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    Bayer announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for Aliqopa™ (copanlisib) for the treatment of adult patients with relapsed marginal zone lymphoma (MZL) who have received at least two prior therapies. MZL is an indolent form of non-Hodgkin’s Lymphoma (iNHL) and accounts for about 10% of all non-Hodgkin’s Lymphoma in the U.S.1

    The Breakthrough Therapy Designation was granted based on data from the MZL subgroup of the pivotal Phase II CHRONOS-1 study, which is the trial that accelerated the U.S. FDA approval of Aliqopa for the treatment of adult patients with relapsed follicular lymphoma (FL) – the most common histological subtype of iNHL – who have received at least two prior systemic therapies. Accelerated approval was granted for this indication based on overall response rate (ORR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

    Aliqopa is an intravenous phosphatidylinositol-3-kinase (PI3K) inhibitor with inhibitory activity predominantly against the PI3K-alpha and PI3K-delta isoforms expressed in malignant B cells. The compound is currently not approved by the European Medicines Agency (EMA) or other authorities outside of the U.S.

    “The clinical evidence suggests that Aliqopa may address an unmet medical need by providing physicians and MZL patients with a therapy in a relapsed setting,” said Dr. Scott Z. Fields, M.D., Senior Vice President and Head of Oncology Development at Bayer’s Pharmaceutical Division. “We will continue working closely with the FDA in order to bring Aliqopa to these underserved patients as soon as possible.”


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