TIDMAZN
RNS Number : 4861R
AstraZeneca PLC
09 December 2016
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.
Media Enquiries
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Investor Relations
Thomas Kudsk Larsen +44 203 749 5712
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Mitchell Chan Oncology +1 240 477 3771
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Nick Stone Respiratory +44 203 749 5716
Christer Gruvris Autoimmunity, neuroscience & infection +44 203 749 5711
US toll free +1 866 381 7277
Adrian Kemp
Company Secretary, AstraZeneca PLC
This information is provided by RNS
The company news service from the London Stock Exchange
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