[August 01, 2017] |
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Acalabrutinib Granted Breakthrough Therapy Designation by US FDA for the Treatment of Patients with Mantle Cell Lymphoma
AstraZeneca and its hematology research and development center of
excellence, Acerta Pharma, today announced that the US Food and Drug
Administration (FDA) has granted Breakthrough Therapy Designation for
acalabrutinib for the treatment of patients with mantle cell lymphoma
(MCL (News - Alert)) who have received at least one prior therapy. Acalabrutinib is an
investigational, highly selective, potent Bruton tyrosine kinase (BTK)
inhibitor in development for the treatment of multiple B-cell cancers.
The Breakthrough Therapy Designation is designed to expedite the
development and regulatory review of new medicines that are intended to
treat a serious condition and that have shown encouraging early clinical
results, which demonstrate substantial improvement on a
clinically-significant endpoint over available therapies and when there
is significant unmet medical need.
Sean Bohen, Executive Vice President, Global Medicines Development and
Chief Medical Officer at AstraZeneca, said: "New treatments are urgently
needed for people with mantle cell lymphoma who relapse or do not
respond to therapy. Breakthrough Therapy Designation for acalabrutinib
will help us bring this potential medicine to appropriate patients as
quickly as possible."
The FDA granted Breakthrough Therapy Designation based on the totality
of clinical data from the acalabrutinib development program, including
data from the Phase II ACE-LY-004 clinical trial in patients with
relapsed or refractory MCL.
Flavia Borellini, PhD, Acerta Pharma Chief Executive Officer, said:
"This is an exciting regulatory milestone for our work in hematology.
Acalabrutinib is a potent, irreversible BTK inhibitor with a high degree
of specificity for its target. If approved, it could be a clinically
meaningful treatment option for patients with this devastating disease."
This is the fifth Breakthrough Therapy Designation that AstraZeneca has
received from the FDA for an oncology medicine since 2014, and the first
for the Company in hematology. The acalabrutinib development program
includes both monotherapy and combination therapies in a broad range of
blood cancers and solid tumors.
NOTES TO EDITORS
About mantle cell lymphoma (MCL) Mantle cell lymphoma (MCL)
is an aggressive B-cell non-Hodgkin lymphoma (NHL) with poor prognosis.1,2,3,4
MCL accounts for approximately 3% to 6% of new NHL cases in Western
countries each year, with an annual incidence of 0.5 per 100,000 persons
and an estimated prevalence of 3.5/100,000.2,5 The median age
at diagnosis is 68 years, with a 3:1 male predominance.2
About acalabrutinib Acalabrutinib is an investigational
highly selective, potent, covalent inhibitor of Bruton tyrosine kinase
(BTK) with minimal off-target activity observed in pre-clinical trials.6,7,8
This potential new medicine is in development for the treatment of
multiple B-cell and other cancers. The acalabrutinib development program
includes both monotherapy and combination therapy strategies in chronic
lymphocytic leukemia (CLL), MCL, Waldenström macroglobulinemia,
follicular lymphoma, diffuse large B-cell lymphoma, and multiple
myeloma, as well as monotherapy and combination trials in solid tumors.
In total, more than 25 acalabrutinib clinical trials with more than
2,000 patients are underway or have completed. Acalabrutinib was granted
Orphan Drug Designation by the FDA for the treatment of patients with
MCL in September 2015. Acalabrutinib is a potential new medicine not
approved for any current use.
About Acerta Pharma Acerta Pharma, a member of the
AstraZeneca Group, is creating novel selective therapies intended for
the treatment of cancer and autoimmune diseases. AstraZeneca acquired a
majority stake interest in Acerta Pharma, which serves as AstraZeneca's
hematology research and development center of excellence. For more
information, please visit www.acerta-pharma.com.
About AstraZeneca in Oncology AstraZeneca has a deep-rooted
heritage in Oncology and offers a quickly growing portfolio of new
medicines that have the potential to transform patients' lives and the
Company's future. With at least six new medicines to be launched between
2014 and 2020 and a broad pipeline of small molecules and biologics in
development, we are committed to advance New Oncology as one of
AstraZeneca's five Growth Platforms focused on lung, ovarian, breast and
blood cancers. In addition to our core capabilities, we actively pursue
innovative partnerships and investments that accelerate the delivery of
our strategy as illustrated by our investment in Acerta Pharma in
hematology.
By harnessing the power of four scientific platforms - Immuno-Oncology,
Tumor Drivers and Resistance, DNA Damage Response and Antibody Drug
Conjugates - and by championing the development of personalized
combinations, AstraZeneca has the vision to redefine cancer treatment
and one day eliminate cancer as a cause of death.
About AstraZeneca AstraZeneca is a global, science-led
biopharmaceutical company that focuses on the discovery, development and
commercialization of prescription medicines, primarily for the treatment
of diseases in three main therapy areas - Oncology, Cardiovascular &
Metabolic Diseases and Respiratory. The Company also is selectively
active in the areas of autoimmunity, neuroscience and infection.
AstraZeneca operates in over 100 countries and its innovative medicines
are used by millions of patients worldwide. For more information, please
visit www.astrazeneca-us.com
and follow us on Twitter (News - Alert) @AstraZenecaUS.
References
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1.
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Leukemia & Lymphoma Society. Mantle Cell Lymphoma Facts. Available
Online. Accessed June 2017.
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Cheah CY, Seymour JF, Wang M. Mantle Cell Lymphoma. Journal of
Clinical Oncology 34, no. 11 (April 2016) 1256-1269.
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Hoster E, Klapper W et al. Confirmation of the Mantle-Cell
Lymphoma International Prognostic Index in Randomized Trials of
the European Mantle-Cell Lymphoma Network. Journal of Clinical
Oncology 2014;32:1338-1346.
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Dreyling M, Ferrero S. The role of targeted treatment in mantle cell
lymphoma: is transplant dead or alive? Haematologica 2016 Volume
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Orphanet Report Series. Prevalence and incidence of rare diseases:
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Covey T, Barf T, Gulrajani M, Krantz F, van Lith B, Bibikova E, et
al. Abstract 2596: ACP-196: a novel covalent Bruton's tyrosine
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Byrd JC, Harrington B, O'Brien S, Jones JA, Schuh A, Devereux S, et
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Harrington BK, Gulrajani M, Covey T, Kaptein A, Van Lith B, Izumi R,
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US- 11256 Last Updated 8/17
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