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) 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 acalabrutinibAcalabrutinib 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, Waldenstr�m 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 PharmaAcerta 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 OncologyAstraZeneca 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 AstraZenecaAstraZeneca 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 @AstraZenecaUS.
References
1.
Leukemia & Lymphoma Society. Mantle
Cell Lymphoma Facts. Available Online. Accessed June 2017.
2.
Cheah CY, Seymour JF, Wang M. Mantle Cell
Lymphoma. Journal of Clinical Oncology 34, no. 11 (April 2016)
1256-1269.
3.
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.
4. Dreyling M, Ferrero S. The role of targeted treatment in mantle
cell lymphoma: is transplant dead or alive? Haematologica 2016
Volume 101(2):104-114 5. Orphanet Report Series. Prevalence and
incidence of rare diseases: Bibilographic data. Number 2 March
2016. 6. 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 kinase (Btk) inhibitor with improved selectivity
and in vivo target coverage in chronic lymphocytic leukemia (CLL)
patients. Cancer Res. 2015;75(15 Supplement):2596. 7. Byrd JC,
Harrington B, O'Brien S, Jones JA, Schuh A, Devereux S, et al.
Acalabrutinib (ACP-196) in relapsed chronic lymphocytic leukemia. N
Engl J Med. 2016;374(4):323–32. 8. Harrington BK, Gulrajani M,
Covey T, Kaptein A, Van Lith B, Izumi R, et al. ACP-196 is a second
generation inhibitor of Bruton tyrosine kinase (BTK) with enhanced
target specificity. Blood. 2015;126(23):2908.
US- 11256 Last Updated 8/17
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