AstraZeneca Updates US Label For FASLODEX® (fulvestrant) Injection

  AstraZeneca Updates US Label For FASLODEX® (fulvestrant) Injection

Updated FASLODEX 500 mg label includes latest CONFIRM (COmparisoN of Faslodex
 In Recurrent or Metastatic breast cancer) overall survival data, additional
           two-year carcinogenesis study conducted in rats and mice

Business Wire

WILMINGTON, Del. -- December 05, 2012

AstraZeneca (NYSE: AZN) today announced agreement with the US Food and Drug
Administration (FDA) on label changes for FASLODEX^® (fulvestrant) Injection.

The update to the FASLODEX US Prescribing Information includes results and a
Kaplan-Meier plot of the final overall survival (OS) analysis from CONFIRM
(COmparisoN of FASLODEX In Recurrent or Metastatic breast cancer), the pivotal
study supporting FASLODEX 500 mg. After a minimum follow-up duration of 50
months, an updated OS analysis was performed. The updated OS data showed a 4.1
month difference in median OS when using FASLODEX 500mg compared to 250 mg.
These results are not statistically significant as no adjustments were made
for multiplicity.^1

FASLODEX 500 mg is indicated for the treatment of hormone receptor-positive
metastatic breast cancer in postmenopausal women with disease progression
following antiestrogen therapy. FASLODEX is contraindicated in patients with
known hypersensitivity to the drug or to any of its components.
Hypersensitivity reactions, including urticaria and angioedema have been
reported in association with FASLODEX. Please see additional important safety
information below.

FASLODEX 500 mg increased progression-free survival, the primary end point in
CONFIRM, with a relative risk reduction of 20% (hazard ratio [HR] 0.80; 95%
confidence interval [CI] 0.68-0.94; p=0.006) compared with FASLODEX 250 mg.
Median progression free survival with FASLODEX 500 mg was found to be 6.5
months compared with 5.5 months with FASLODEX 250 mg. In the initial analysis
after a minimum follow-up duration of 18 months, there was no statistically
significant difference in OS between the two treatment groups. The results of
the final OS analysis were analyzed in 2011, when the OS data had reached 75%
maturity (75% of patients had died).^1

The updated FDA label for FASLODEX also includes information from an
additional two-year carcinogenesis study conducted in rats and mice. Positive
findings were observed in both species. Rats were treated with intramuscular
doses of 15 mg/kg/30 days, 10 mg/rat/30 days and 10 mg/rat/15 days. These
doses correspond to 0.9-, 1.5-, and 3-fold (in females) and 0.8-, 0.8-, and
2-fold (in males) the systemic exposure achieved in women receiving the
recommended dose of 500 mg/month.^1

Important Safety Information About FASLODEX^® (fulvestrant) Injection

  *FASLODEX is contraindicated in patients with known hypersensitivity to the
    drug or to any of its components. Hypersensitivity reactions, including
    urticaria and angioedema have been reported in association with FASLODEX
  *Because FASLODEX^® (fulvestrant) Injection is administered
    intramuscularly, it should be used with caution in patients with bleeding
    diatheses, thrombocytopenia, or in patients on anticoagulants
  *FASLODEX is metabolized primarily in the liver. A 250-mg dose is
    recommended in patients with moderate hepatic impairment. FASLODEX has not
    been evaluated in patients with severe hepatic impairment (Child-Pugh
    Class C)
  *Fetal harm can occur when administered to a pregnant woman. Women should
    be advised of the potential hazard to the fetus and to avoid becoming
    pregnant while receiving FASLODEX
  *The most common, clinically significant adverse reactions occurring in ≥5%
    of patients receiving FASLODEX were: injection site pain, nausea, bone
    pain, arthralgia, headache, back pain, fatigue, pain in extremity, hot
    flash, vomiting, anorexia, asthenia, musculoskeletal pain, cough, dyspnea,
    and constipation
  *Increased hepatic enzymes (ALT, AST, ALP) occurred in >15% of FASLODEX
    users and were non dose-dependent

Indication for FASLODEX^® (fulvestrant) Injection

FASLODEX is indicated for the treatment of hormone receptor-positive
metastatic breast cancer in postmenopausal women with disease progression
following antiestrogen therapy.

Please see full Prescribing Information for FASLODEX.

You are encouraged to report negative side effects of prescription drugs to
the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

FASLODEX is a registered trademark of the AstraZeneca group of companies.

                                   – ENDS –

NOTES TO EDITORS

About CONFIRM

CONFIRM (COmparisoN of FASLODEX In Recurrent or Metastatic breast cancer) was
a Phase III, randomized, double-blind, parallel-group, multicenter trial
comparing FASLODEX 500 mg (n=362) and 250 mg (n=374) in postmenopausal women
with estrogen receptor-positive advanced breast cancer, who progressed or
recurred following prior endocrine therapy. Eligible patients were randomized
1:1 to FASLODEX 500 mg or 250 mg, and assessed for tumor progression every 12
weeks. The primary objective was to compare the efficacy of both treatment
groups in terms of progression-free survival. Secondary objectives included:
objective response rate (ORR), clinical benefit rate (CBR), duration of
response, duration of clinical benefit (DoCB), overall survival (OS),
tolerability, and quality of life (QoL).

The final updated CONFIRM OS, performed at 75% maturity, showed a 19% relative
reduction in the risk of death (hazard ratio (HR) 0.81; 95% confidence
interval (CI) 0.69 to 0.96). No adjustments were made for multiplicity,
therefore these data cannot be considered statistically significant. The
median OS for FASLODEX 500 mg and 250 mg was 26.4 months and 22.3 months,
respectively.^1

About Metastatic Breast Cancer

Metastatic breast cancer occurs when cancer cells spread beyond the initial
tumor site to other parts of the breast or body; it is the most advanced stage
of breast cancer (stage four).^2,3 Metastatic breast cancer may be diagnosed
as an initial diagnosis, as a distant recurrence after treatment of early
breast cancer, or as a progression of earlier stage disease.^4,5 There is no
cure for metastatic breast cancer; the goal of treatment is to delay the
progression of the cancer.^3

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business with a
primary focus on the discovery, development and commercialization of
prescription medicines for gastrointestinal, cardiovascular, neuroscience,
respiratory and inflammation, oncology and infectious disease. AstraZeneca
operates in over 100 countries and its innovative medicines are used by
millions of patients worldwide.

For more information about AstraZeneca in the United States or our AZ&Me™
Prescription Savings programs, please visit: www.astrazeneca-us.com or call
1-800-AZandMe (292-6363).

^1 Prescribing Information for FASLODEX. AstraZeneca Pharmaceutical LP,
Wilmington, DE.
^2 National Cancer Institute. Treatment Option Overview, Patient Version.
Available online. Last accessed July 26, 2012.
^3 National Cancer Institute. Metastatic Cancer: Questions and Answers.
Available online. Last accessed July 26, 2012.
^4 Dawood S, Broglio K, Ensor J, Hortobagyi GN, Giordano SH. Survival
differences among women with de novo stage IV and relapsed breast cancer.
Annals Oncol. 2010;21:2169-2174.
^5 American Cancer Society. Treatment of invasive breast cancer, by stage.
Last revised: August 23, 2012. Available Online. Last accessed September 17,
2012.

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Last Updated 12/12

Contact:

AstraZeneca
Media Inquiries US
Rachelle Benson +1 302 885 5853 mob: +1 302 5595861
 
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