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Bayer
Provides Update on
Aliqopa
® (
copanlisib
)
2023-11-13
·
BioSpace
上市批准
临床结果
临床2期
免疫疗法
加速审批
WHIPPANY, N.J.--(BUSINESS WIRE)--
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. About
Bayer
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. For more information, go to . © 2023
Bayer
BAYER
, the
Bayer Cross
and
Aliqopa
are registered trademarks of
Bayer
. Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by
Bayer
management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in
Bayer
’s public reports which are available on the
Bayer
website at . The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
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文中所述内容并不反映新药情报库及其所属公司任何意见及观点,如有版权侵扰或错误之处,请及时联系我们,我们会在24小时内配合处理。
机构
Bayer AG
US Food & Drug Administration
拜耳医药保健有限公司
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