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2017-11-15

AstraZeneca: Faslodex receives US FDA approval for the treatment of advanced breast cancer in combination with abemaciclib

Faslodex in combination with abemaciclib showed 16.4 months of
progression-free survival (PFS)

Second approval in three months expands treatment options for women
with HR+, HER2- advanced breast cancer

AstraZeneca today announced that the US Food and Drug Administration
(FDA) has approved a new indication for Faslodex (fulvestrant),
expanding the indication to include use with abemaciclib, a CDK4/6
inhibitor, for the treatment of hormone receptor-positive (HR+),
human epidermal growth factor receptor 2 negative (HER2-) advanced or
metastatic breast cancer (MBC) in women with disease progression
after endocrine therapy.

Dave Fredrickson, Executive Vice President, Head of the Oncology
Business Unit at AstraZeneca, said: "Faslodex has long been an
effective monotherapy option for women with hormone receptor positive
breast cancer, which is the most common type of advanced breast
cancer. Today's decision builds upon the recent approval
(https://www.astrazeneca.com/media-centre/press-releases/2017/faslodex-re...)
for Faslodex in the first-line advanced setting and is supported by
strong evidence to use this medicine within a combination therapy for
advanced breast cancer. Combining Faslodex with abemaciclib provides
patients with another effective, non-chemotherapy option to combat
this disease."

Peter A. Kaufman, MD of the Norris Cotton Cancer Center at
Dartmouth-Hitchcock Medical Center, said: "This new indication for
Faslodex offers another treatment option for women living with HR+,
HER2- advanced or metastatic breast cancer with disease progression
after endocrine therapy. The study supporting this indication
demonstrated that Faslodex used in combination with abemaciclib
significantly improves progression-free survival compared to Faslodex
and placebo."

The FDA approval is based on data from the Phase III MONARCH 2 trial
(https://investor.lilly.com/releasedetail.cfm?ReleaseID=1017952),
which met the study's primary endpoint of PFS.

The trial included 669 women with HR+, HER2- advanced breast cancer.
The results showed a statistically significant increase in
investigator-assessed median PFS of 7.1 months (16.4 months vs 9.3
months) in patients who received Faslodex 500 mg and abemaciclib 150
mg over Faslodex and placebo (HR: 0.553; 95% CI: 0.449-0.681;
p<0.0001).

This expanded indication for Faslodex is the second FDA approval for
Faslodex in combination with a CDK4/6 inhibitor. Faslodex has been
licensed in the US since 2016 for use with the CDK4/6 inhibitor,
palbociclib, for the treatment of women with HR+, HER2-negative MBC,
whose cancer has progressed after endocrine therapy.

- ENDS -

NOTES TO EDITORS

About MONARCH 2

MONARCH 2 is a Phase III, international, randomised, double-blind,
placebo-controlled, multicenter study, sponsored by Eli Lilly and
Company, of Faslodex with abemaciclib vs Faslodex with placebo
conducted in women with HR+, HER2- advanced or metastatic breast
cancer, whose disease progressed on or after neoadjuvant or adjuvant
endocrine therapy, ?12 months from the end of adjuvant endocrine
therapy, or while receiving first-line endocrine therapy for
metastatic disease. The study included 669 women randomly assigned to
receive intramuscular injection of 500 mg Faslodex with abemaciclib
or placebo orally twice daily in a 2:1 ratio. Pre/perimenopausal
women were enrolled in the study and received the
gonadotropin-releasing hormone agonist goserelin acetate for at least
four weeks prior to and for the duration of the study. Patients
remained on treatment until development of progressive disease or
unmanageable toxicity.

Patients enrolled in this study had a median age of 60 years (range,
32 to 91). The majority of patients in the study were white (56%).
All patients had an ECOG (Eastern Cooperative Oncology Group)
performance status of 0 or 1.

Approximately 59% of patients in each of the treatment arms, Faslodex
in combination with abemaciclib and Faslodex with placebo, received
endocrine therapy as their first therapy for advanced breast cancer;
the remaining 38% of patients in the experimental and in the control
treatment arms received this regimen as their second endocrine
therapy for advanced breast cancer. 55.8% had visceral disease and
26.9% had bone-only disease. Twenty-five percent of patients had
primary endocrine resistance, and 2.7% had locally advanced disease.

Detailed results of the MONARCH 2 trial are published online in the
Journal of Clinical Oncology
(http://ascopubs.org/doi/abs/10.1200/JCO.2017.73.7585?url_ver=Z39.88-2003...).

About Advanced Breast Cancer or Metastatic Breast Cancer (MBC)

Advanced/metastatic breast cancer refers to Stages III and IV breast
cancer. Stage III disease may be referred to as locally-advanced
breast cancer. MBC is the most advanced stage of breast cancer (Stage
IV), and occurs when cancer cells have spread beyond the initial
tumor site to other parts of the body outside of the breast.

Despite treatment options increasing during the past three decades,
there is currently no cure for patients diagnosed with MBC and the
5-year relative survival rate for this patient population is
currently 26.9%. Thus, the primary aim of treatment is to slow
progression of the disease for as long as possible, improving, or at
least maintaining, a patient's quality of life.

It is estimated that in 2017, there will be approximately 153,000
women in the US living with MBC, and this number is projected to
increase to approximately 160,000 by the year 2020.

About Faslodex (fulvestrant)

Faslodex is indicated for the treatment of oestrogen receptor
positive, locally advanced or metastatic breast cancer in
postmenopausal women not previously treated with endocrine therapy,
or with disease relapse on or after adjuvant anti-oestrogen therapy,
or disease progression on anti-oestrogen therapy.

In the US, EU and Japan, Faslodex is also approved in combination with
palbociclib for the treatment of women with HR+, HER2-negative
advanced or metastatic breast cancer, whose cancer has progressed
after endocrine medicine. Faslodex represents a hormonal treatment
approach that helps to slow tumour growth by blocking and degrading
the oestrogen receptor - a key driver of disease progression.

Faslodex is approved in over 80 countries as a monotherapy to treat
ER+ advanced breast cancer patients. It is currently being evaluated
in combination with medicines from various drug classes for the
treatment of women with HR+ advanced breast cancer.

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 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.

Media Relations
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