Whippany, N.J., November 13, 2023 –Bayer today announced that, following discussions with the U.S. Food and Drug Administration (FDA), it will work with the FDA on a voluntary withdrawal of the Aliqopa® (copanlisib) U.S. New Drug Application for adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies.
Aliqopa® was granted accelerated approval by the FDA in September 2017 based on CHRONOS-1, an open-label, single-arm Phase II study. The FDA required clinical benefit to be confirmed through the CHRONOS-4 study. In the study, the addition of Aliqopa® to standard immunochemotherapy regimens did not meet the primary endpoint of progression-free survival benefit versus the standard immunochemotherapy control arm in patients with relapsed follicular lymphoma. Bayer intends to publish the results of CHRONOS-4 in a timely manner.
Bayer is exploring access options for patients currently receiving Aliqopa® who have experienced a favorable response to treatment, whose treating physician supports continuing treatment with Aliqopa®, and for whom there may be no suitable alternative treatments available. Patients currently being treated with Aliqopa® should consult their healthcare provider. No new patients should be prescribed Aliqopa®. For questions related to ongoing access, please contact Bayer Medical Communications at 1-888-84-Bayer.
About non-Hodgkin’s lymphoma
Non-Hodgkin’s Lymphoma (NHL) comprises a highly heterogeneous group of chronic diseases with poor prognosis. NHL is the most common hematologic malignancy and the tenth most common cancer worldwide.
About Copanlisib (Aliqopa®)
Copanlisib is currently approved in the U.S., China and Taiwan as a monotherapy under the brand name Aliqopa® for the treatment of adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies.
About Oncology at Bayer
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer includes six marketed products and several other assets in various stages of clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2022, the Group employed around 101,000 people and had sales of 50.7 billion euros. R&D expenses before special items amounted to 6.2 billion euros.
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