AstraZeneca (NYSE: AZN) today announced the presentation of important new data from studies of FASLODEX ® (fulvestrant) Injection at the 2012 CTRC-AACR San Antonio Breast Cancer Symposium taking place from 4-8 December at the Henry B. Gonzalez Convention Center, San Antonio, Texas. This will include final analysis of overall survival from the Phase III CONFIRM trial (COmparisoN of Faslodex In Recurrent or Metastatic breast cancer) comparing fulvestrant 500 mg vs 250 mg.
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. 1
“The study data and research findings that will be presented are a further addition to AstraZeneca’s ongoing commitment to the continued study and evaluation of treatment options for metastatic breast cancer. While some of the data and research are investigational, it highlights AstraZeneca’s ongoing pursuit to developing and optimizing breast cancer treatments for patients,” said Yuri Rukazenkov, MD, Medical Science Director, AstraZeneca.
Highlighted study results to be presented:
- Final overall survival analysis of CONFIRM, 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 whose disease progressed or recurred following prior endocrine therapy, will be presented by Angelo Di Leo, MD, Head of the Sandro Pitigliani Medical Oncology Unit. Study results will also be featured in a SABCS press briefing.
- Data will be presented from a study on overcoming PTEN loss-related endocrine therapy resistance through strategic combinations with mTOR, AKT, or MEK inhibitors.
- Results from a meta-analysis of the EFECT and SoFEA studies of fulvestrant and exemestane in metastatic breast cancer patients with acquired resistance to non-steroidal aromatase inhibitors. The SoFEA trial is a Phase III study evaluating safety and efficacy of fulvestrant plus concomitant anastrozole in postmenopausal women with advanced hormone receptor-positive breast cancer compared with fulvestrant or exemestane alone. Results of the EFECT trial, a randomized, double-blind,placebo controlled, multicenter phase III trial of fulvestrant versus exemestane in postmenopausal women with hormone receptor-positive advanced breast cancer progressing or recurring after nonsteroidal aromatase inhibitors, were published in 2008 in the Journal of Clinical Oncology.
- First results from the UNICANCER CARMINA 02 French Trial, a randomized Phase II neoadjuvant trial evaluating anastrozole and fulvestrant in post-menopausal estrogen receptor-positive, HER2-negative breast cancer will be presented. The UNICANCER CARMINA study focuses on the neo-adjuvant treatment of operable breast cancer in postmenopausal women with stage II or stage III disease.
- 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