By a News Reporter-Staff News Editor at Politics & Government Week AstraZeneca announced that the US Food and Drug Administration (FDA) has approved FASLODEX (fulvestrant) 500mg as monotherapy for expanded use in women with hormone-receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer, who have gone through menopause and have not received previous endocrine therapy.1 The FDA approval is based on pivotal data from the Phase III FALCON trial, which were published in the November 2016 issue of The Lancet.2 Jamie Freedman, Executive Vice President, Head of the Oncology Business Unit, AstraZeneca said: "We're pleased that the landmark FALCON trial results demonstrated the efficacy of FASLODEX as initial monotherapy treatment for women who are living with HR+, HER2- advanced breast cancer. This approval, building on more than 15 years of clinical experience, means more patients can have the opportunity to receive FASLODEX earlier in the treatment journey."
Matthew Ellis, MD, PhD, Director of the Lester and Sue Smith Breast Center, part of the NCI-designated Dan L Duncan Comprehensive Cancer Center at Baylor College of Medicine said: "This study provides evidence that using fulvestrant as the first option for previously untreated hormone receptor-positive advanced breast cancer will prolong the time before the disease advances and alternative therapies are required."
The FALCON trial was designed to demonstrate superiority and included 462 postmenopausal women with HR+ metastatic or locally-advanced breast cancer. The results showed a statistically-significant increase in investigator-assessed median progression-free survival (PFS), representing a 20% reduction in the risk of disease progression or death determined by RECIST - median PFS of 16.6 months in patients who received FASLODEX, compared to 13.8 months in patients receiving the aromatase inhibitor ARIMIDEX (anastrozole) 1mg (HR: 0.797; 95% CI: 0.637-0.999; p=0.049).1 FASLODEX is a hormonal therapy that targets the estrogen receptor (ER), which can influence the growth of HR+ metastatic breast cancer (MBC), and helps to slow cancer growth by blocking the ER and targeting it for degradation.1,3,4,5 The most common adverse reactions (=10%) of any grade reported in patients in the FASLODEX arm were arthralgia, hot flash, fatigue, and nausea.1 First approved in 2002, FASLODEX has been used as a monotherapy for the treatment of postmenopausal women with HR+ MBC whose cancer has progressed following prior antiestrogen therapy.6 In 2016, FASLODEX was approved by the FDA in combination with palbociclib, for the treatment of women with HR+, HER2- advanced or MBC, whose cancer has progressed after endocrine therapy.1,7 Important Safety Information About FASLODEX Contraindications 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 Risk of Bleeding Because FASLODEX is administered intramuscularly, it should be used with caution in patients with bleeding diatheses, thrombocytopenia, or anticoagulant use Hepatic Impairment FASLODEX is metabolized primarily in the liver. A 250-mg dose is recommended in patients with moderate hepatic impairment (Child-Pugh class B). FASLODEX has not been evaluated in patients with severe hepatic impairment (Child-Pugh class C) Injection Site Reaction Use caution while administering FASLODEX at the dorsogluteal injection site due to the proximity of the underlying sciatic nerve. Injection site related events including sciatica, neuralgia, neuropathic pain, and peripheral neuropathy have been reported with FASLODEX injection Embryo-Fetal Toxicity and Lactation Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during FASLODEX treatment and for 1 year after the final dose. Advise lactating women not to breastfeed during treatment with FASLODEX and for 1 year after the final dose because of the potential risk to the infant Immunoassay Measurement of Serum Estradiol Due to structural similarity of fulvestrant and estradiol, FASLODEX can interfere with estradiol measurement by immunoassay, resulting in falsely elevated estradiol levels Adverse Reactions Monotherapy The most common adverse reactions occurring in =5% of patients receiving FASLODEX 500 mg were: injection site pain, nausea, bone pain, arthralgia, headache, back pain, fatigue, pain in extremity, hot flash, myalgia, vomiting, anorexia, diarrhea, asthenia, musculoskeletal pain, cough, dyspnea, and constipation
Increased hepatic enzymes (ALT, AST, ALP) occurred in >15% of FASLODEX patients and were not dose-dependent Combination Therapy The most frequently reported serious adverse reactions in patients receiving FASLODEX plus palbociclib were infections (3%), pyrexia (1%), neutropenia (1%), and pulmonary embolism (1%)
Keywords for this news article include: FDA, Antineoplastics, Oncology, Estradiol, AstraZeneca, Fulvestrant, Hot Flashes, Sex Hormones, Breast Cancer, Vaginal Agents, Women's Health, Drugs and Therapies, Risk and Prevention, Vaginal Preparations, Diseases and Conditions, Hormone Replacement Therapy, Estrogen Receptor Antagonists, U.S. Food and Drug Administration.
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