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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
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.
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).
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.
1Important 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.