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FDA Approves New Dosing for FASLODEX® (fulvestrant) Injection in Treatment of Metastatic Breast Cancer in HR+ Postmenopausal Women
Date:9/10/2010

ASLODEX 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.

Approved Use For FASLODEX

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. If you have any questions concerning FASLODEX, please contact AstraZeneca Information Center at 1-800-236-9933, open Monday to Friday from 8 AM to 6 PM, excluding holidays.

About CONFIRM

CONFIRM (COmparisoN of FASLODEX In Recurrent or Metastatic breast cancer) was a Phase III, randomized, double-blind, parallel-group, multi-center trial comparing fulvestrant 500 mg (n=362) and 250 mg (n=374) in postmenopausal women with estrogen receptor-positive advanced breast cancer, who progressed or recurred following one prior endocrine therapy (antiestrogen or aromatase inhibitor). Eligible patients were randomized 1:1 to fulvestrant 500mg or 250mg, 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 clinical ben
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SOURCE AstraZeneca
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