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

WILMINGTON, Del.--(BUSINESS WIRE)-- AstraZeneca (NYS: 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 500 mg 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

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