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 December 2016
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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This
announcement contains inside information
9
December 2016 15:00
US
FDA ACCEPTS FIRST BIOLOGICS LICENSE APPLICATION FOR
ASTRAZENECA’S DURVALUMAB IN BLADDER CANCER
FDA
grants priority review status with PDUFA set for Q2
2017
AstraZeneca and its
global biologics research and development arm, MedImmune, today
announced that the US Food and Drug Administration (FDA) has
accepted the first Biologics License Application (BLA) for
durvalumab, a PD-L1 human monoclonal antibody (mAb), and granted
priority review status with a Prescription Drug User Fee Act
(PDUFA) set for the second quarter of 2017.
The BLA
submission, for the treatment of patients with locally advanced or
metastatic urothelial carcinoma (UC) whose disease has progressed
during or after one standard platinum‑based regimen, is
based on the results of the UC cohort of Study 1108 and follows the
FDA's
February 2016 Breakthrough Therapy Designation for
durvalumab.
Sean
Bohen, Executive Vice President, Global Medicines Development and
Chief Medical Officer at AstraZeneca, said: "The BLA acceptance of
durvalumab in urothelial cancer is an important milestone for
patients who still face considerable unmet medical need in this
area. It also represents an exciting advance for our
Immuno-Oncology medicines as we continue to develop
chemotherapy-free treatments based on the potential clinical
benefits of durvalumab, both as monotherapy and in
combination."
As part
of a broad development programme, durvalumab is being tested as
monotherapy and in combination with tremelimumab (CTLA-4 mAb) in
the Phase III DANUBE trial as 1st-line treatment for patients with
metastatic UC, regardless of eligibility for cisplatin-based
chemotherapy.
The
combination of durvalumab and tremelimumab is also being studied in
Phase III trials in non-small cell lung cancer (NSCLC), head and
neck squamous cell carcinoma (HNSCC) and in Phase II and earlier
trials in gastric cancer, pancreatic cancer, hepatocellular
carcinoma (HCC) and blood cancers. AstraZeneca currently has more
than 30 ongoing durvalumab clinical trials in combination with
other IO agents and targeted therapies.
About
Study 1108
Study
1108 is a Phase I/II multicentre, open-label dose-escalation and
dose-expansion study investigating the safety and efficacy of
durvalumab in adult patients with inoperable or metastatic solid
tumours.
About
Urothelial Cancer (UC)
Urothelial cancer
develops in the cells of the bladder lining (urothelium) and is the
most common type of bladder cancer. UC accounts for more than 90%
of all cases of bladder cancer worldwide and is an area of
significant unmet medical need. Current standard of care for UC
patients with inoperable or advanced metastatic disease is systemic
platinum-based chemotherapy, introduced nearly 30 years
ago.
About
Durvalumab
Durvalumab is an
investigational human monoclonal antibody directed against
programmed death ligand-1 (PD-L1). PD-L1 expression enables tumours
to evade detection from the immune system through binding to PD-1
on cytotoxic T lymphocytes. Durvalumab blocks PD-L1 interaction
with both PD-1 and CD80 on T cells, countering the tumour's immune-
evading tactics and activating the patient's immune system to
attack the cancer. Durvalumab received FDA Breakthrough Therapy
Designation in patients with PD-L1 positive inoperable or
metastatic UC in 2016 and Fast Track Designation in 2015 for the
treatment of patients with PD-L1 positive metastatic head and neck
squamous cell carcinoma.
AstraZeneca's
Approach to Immuno-Oncology (IO)
Immuno-Oncology
(IO) is a therapeutic approach designed to stimulate the body's
immune system to destroy tumours. At AstraZeneca, and MedImmune,
our biologics research and development arm, our IO portfolio is
anchored by immunotherapies that have been designed to overcome
anti-tumour immune suppression. We believe that IO-based therapies
will offer the potential for life-changing cancer treatments for
the vast majority of patients.
We are
pursuing a comprehensive clinical trial programme that includes
durvalumab (PD-L1) monotherapy and durvalumab in combination with
tremelimumab (CTLA-4) in multiple tumour types, stages of disease,
and lines of therapy, using the PD-L1 biomarker as a
decision-making tool to define the best potential treatment path
for a patient. In addition, the ability to combine our IO portfolio
with small targeted molecules from across our oncology pipeline,
and with those of our partners, may provide new treatment options
across a broad range of tumours.
About
AstraZeneca in Oncology
AstraZeneca has a
deep-rooted heritage in Oncology and offers a quickly growing
portfolio of new medicines that has 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 six 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, the genetic drivers of cancer 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
MedImmune
MedImmune is the
global biologics research and development arm of AstraZeneca, a
global, innovation-driven biopharmaceutical business that focuses
on the discovery, development and commercialization of small
molecule and biologic prescription medicines. MedImmune is
pioneering innovative research and exploring novel pathways across
key therapeutic areas, including oncology; respiratory,
inflammation and autoimmunity; cardiovascular and metabolic
disease; and infection and vaccines. The MedImmune headquarters is
located in Gaithersburg, MD., one of AstraZeneca's three global
R&D centres, with additional sites in Cambridge, UK and
Mountain View, CA. For more information, please visit www.medimmune.com.
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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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:
09 December 2016
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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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