Blueprint
FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of August 2017
Commission
File Number: 001-11960
AstraZeneca PLC
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This announcement contains inside information
1 August 2017 07:00 BST
ACALABRUTINIB GRANTED BREAKTHROUGH THERAPY DESIGNATION BY US FDA
FOR THE TREATMENT
OF PATIENTS WITH MANTLE CELL LYMPHOMA
AstraZeneca
and its haematology research and development centre 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 a 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
medicines 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 current therapy. Breakthrough Therapy Designation
for acalabrutinib will help us bring this potential new 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 programme,
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 haematology.
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 haematology. The acalabrutinib development
programme includes both monotherapy and combination therapies for a
broad range of blood cancers and solid tumours.
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 a-calabrutinib
Acalabrutinib
is a 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 programme includes
both monotherapy and combination therapy strategies in chronic
lymphocytic leukaemia (CLL), MCL, Waldenström
macroglobulinemia (WM), follicular lymphoma, diffuse large B-cell
lymphoma, and multiple myeloma, as well as monotherapy and
combination trials in solid tumours. 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 and by the European Commission in March 2016 for the
treatment of patients with CLL, MCL and WM. 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 haematology
research and development centre 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
haematology.
By
harnessing the power of four scientific platforms --
Immuno-oncology, Tumour Drivers and Resistance, DNA Damage Response
and Antibody Drug Conjugates -- and by championing the development
of personalised 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 commercialisation 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.com
and follow us on Twitter
@AstraZeneca.
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References
1Leukemia & Lymphoma Society. Mantle Cell Lymphoma
Facts.
https://www.lls.org/sites/default/files/file_assets/mantlecelllymphoma.pdf
Accessed June
2017
2Cheah CY, Seymour JF, Wang M. Mantle Cell Lymphoma. Journal
of Clinical Oncology 34, no. 11 (April 2016)
1256-1269.
3Hoster 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.
4Dreyling M, Ferrero S. The role of targeted treatment in
mantle cell lymphoma: is transplant dead or alive? Haematologica
2016 Volume 101(2):104-114
5Orphanet Report Series. Prevalence and incidence of rare
diseases: Bibilographic data. Number 2 March 2016.
6Covey 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.
7Byrd 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.
8Harrington 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.
Adrian Kemp
Company Secretary
AstraZeneca PLC
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
AstraZeneca
PLC
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Date:
01 August 2017
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By: /s/
Adrian Kemp
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Name:
Adrian Kemp
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Title:
Company Secretary
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