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 November
2019
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
US
FDA accepts regulatory submission for selumetinib
in
neurofibromatosis type 1 and grants Priority Review
14 November 2019 07:00 GMT
US FDA accepts regulatory submission for selumetinib
in neurofibromatosis type 1 and grants Priority Review
AstraZeneca and MSD's selumetinib would become the first medicine
indicated for the treatment of paediatric patients with NF1
plexiform neurofibromas if approved
AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck
& Co., Inc. inside the US and Canada) today announced that
the US Food and Drug Administration (FDA) has accepted a New Drug
Application (NDA) and granted Priority Review
for selumetinib as a potential new medicine for
paediatric patients aged three years and older with
neurofibromatosis type 1 (NF1) and symptomatic, inoperable
plexiform neurofibromas (PNs).
This is the first acceptance of a regulatory submission for an oral
monotherapy for the treatment of NF1, a rare and incurable genetic
condition. A Prescription Drug User Fee Act (PDUFA) date is
set for the second quarter of 2020.
The regulatory submission was based on positive results from the
National Cancer Institute (NCI) Cancer Therapy Evaluation Program
(CTEP)-sponsored SPRINT Phase II Stratum 1 trial. An Objective
Response Rate (ORR) was achieved in 66% of paediatric patients with
NF1 and symptomatic, inoperable PNs (n=33/50 patients) when
treated with selumetinib as a twice-daily oral monotherapy. ORR was
defined as the percentage of patients with a confirmed complete or
partial response of ≥ 20% tumour volume
reduction.
Selumetinib, a MEK 1/2 inhibitor was granted US
FDA Breakthrough Therapy
Designation in April
2019, Orphan Drug Designation in February
2018, EU Orphan
Designation in August
2018 and Swissmedic Orphan Drug Status in December
2018. AstraZeneca and MSD
are jointly developing and commercialising selumetinib globally
under a license agreement.
About SPRINT
SPRINT is a US NCI CTEP-sponsored Phase I/II trial. The Phase I
trial was designed to identify the optimal Phase II dosing regimen,
and the results were published in The New
England Journal of Medicine.1
About selumetinib
Selumetinib is a MEK 1/2 inhibitor. It is designed to inhibit the
MEK enzyme in the RAS/MAPK pathway, a cell-signalling pathway,
associated with cancer cell growth and proliferation in a number of
different tumour types.
About NF1
NF1 is an incurable genetic condition that affects one in every
3,000 to 4,000 individuals.2,3 It
is caused by a spontaneous or inherited mutation in
the NF1 gene and is associated with many symptoms,
including soft lumps on and under the skin (cutaneous
neurofibromas), skin pigmentation (so-called 'cafe au
lait' spots) and, in 30-50% of patients, tumours develop on
the nerve sheaths (plexiform neurofibromas).1 These
plexiform neurofibromas can cause clinical issues such as pain,
motor dysfunction, airway dysfunction, bowel/bladder dysfunction
and disfigurement as well as having the potential to transform into
malignant peripheral nerve sheath tumours
(MPNST).1
People with NF1 may experience a number of complications such as
learning difficulties, visual impairment, twisting and curvature of
the spine, high blood pressure, and epilepsy. NF1 also increases a
person's risk of developing other cancers, including malignant
brain tumours, MPNST and leukaemia. Symptoms begin during early
childhood, with varying degrees of severity, and can reduce life
expectancy by up to 15 years.4
About the AstraZeneca and MSD strategic oncology
collaboration
In July
2017, AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US,
known as MSD outside the United States and Canada, announced a
global strategic oncology collaboration to co-develop and
co-commercialise Lynparza, the world's first PARP
inhibitor, and potential new medicine selumetinib, a MEK inhibitor,
for multiple cancer types. Working together, the companies will
develop Lynparza and selumetinib in
combination with other potential new medicines and as
monotherapies. Independently, the companies will
develop Lynparza and selumetinib in
combination with their respective PD-L1 and PD-1
medicines.
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 Oncology as one of AstraZeneca's four 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 therapy areas - Oncology, Cardiovascular, Renal and
Metabolism, and Respiratory. AstraZeneca operates in over 100
countries and its innovative medicines are used by millions of
patients worldwide. Please visit astrazeneca.com and
follow the Company on Twitter @AstraZeneca.
Media
Relations
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Gonzalo
Viña
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+44 203
749 5916
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Rob
Skelding
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Oncology
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+44 203
749 5821
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Rebecca
Einhorn
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Oncology
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+1 301
518 4122
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Matt
Kent
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BioPharmaceuticals
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+44 203
749 5906
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Jennifer
Hursit
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Other
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203 749 5762
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Hägerstrand
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+46 8 552 53 106
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Michele
Meixell
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US
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+1 302
885 2677
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Investor
Relations
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Thomas
Kudsk Larsen
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Henry
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(CV, Metabolism)
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Nick
Stone
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BioPharmaceuticals
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+44 203
749 5716
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Afolabi
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(Respiratory),
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+44 203
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References
1. Dombi E, et al. Activity of Selumetinib in Neurofibromatosis
Type 1-Related Plexiform Neurofibromas. N Engl J
Med.
2016;375:2550-2560.
2. National Institute of Neurological Disorders and Stroke.
Neurofibromatosis Fact Sheet. "What is NF1?" Available
at: https://www.ninds.nih.gov/disorders/patient-caregiver-education/fact-sheets/neurofibromatosis-fact-sheet
#3162_2 Accessed October
2019.
3. ASCO Cancer.Net. Neurofibromatosis Type 1. Available
at https://www.cancer.net/cancer-types/neurofibromatosis-type-1 Accessed
June 2019.
4. Evans DGR, et al. Reduced Life Expectancy Seen in Hereditary
Diseases Which Predispose to Early-Onset
Tumors. Appl Clin
Genet.
2013;6:53-61.
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.
Date:
14 November
2019
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
|