New Initial Monotherapy for Women with Advanced Breast Cancer Now Available
AstraZeneca is pleased to announce on August 25, 2017, the FDA has approved FASLODEX® (fulvestrant) for earlier use in the treatment journey, as initial monotherapy for postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer not previously treated with endocrine therapy. The new indication offers another option for an additional population of women battling advanced stages of this complex disease.
This approval is based on data from the Phase III FALCON trial, which included 462 postmenopausal women, that showed a statistically significant increase in median progression-free survival (PFS) – 16.6 months in patients who received FASLODEX, compared to 13.8 months in patients receiving the aromatase inhibitor, ARIMIDEX® (anastrozole), a current standard of care.
The most common adverse reactions ≥10% of any grade reported in patients in the FASLODEX arm were arthralgia, hot flash, fatigue, and nausea. Adverse reactions reported in patients who received FASLODEX in FALCON at an incidence of ≥5% in either treatment arm were hot flash, nausea, diarrhea, arthralgia, myalgia, pain in extremity, back pain, and fatigue. Please see additional Important Safety Information below.
For more information regarding the approval, please see AstraZeneca’s release announcing the news here.
For more information please visit www.faslodexhcp.com
Important Safety Information About FASLODEX
You should not receive FASLODEX if you have had an allergic reaction to fulvestrant or any of the ingredients in FASLODEX. Talk to your health care professional if you experience symptoms of an allergic reaction to FASLODEX which may include: itching or hives; swelling of your face, lips, tongue, or throat; trouble breathing.
Before receiving FASLODEX, tell your health care provider about all of your medical conditions, including if you:
- Have a low level of platelets in your blood or bleed easily. Especially tell your health care provider if you take a blood thinner medicine (anticoagulants)
- Have liver problems
- Are pregnant or plan to become pregnant, as FASLODEX can harm your unborn baby
– Females who are able to become pregnant should use effective birth control during treatment with FASLODEX and for 1 year after the final dose
-Tell your health care provider right away if you become pregnant or think you are pregnant while on FASLODEX
- Are breastfeeding or plan to breastfeed. It is not known if FASLODEX passes into breast milk. Do not breastfeed during treatment with FASLODEX and for 1 year after the final dose. Talk to your health care provider about the best way to feed your baby during this time
Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. FASLODEX may affect the way other medicines work, and other medicines may affect how FASLODEX works.
FASLODEX is administered by your health care provider as an injection into the muscle of each buttock. Your health care provider may change your dose of FASLODEX if needed.
FASLODEX may cause injection site related nerve damage. Call your health care provider if you develop any of the following symptoms in your legs following a FASLODEX injection: numbness, tingling, or weakness.
Common side effects of FASLODEX include: injection site pain; nausea; muscle, joint, and bone pain; headache; tiredness; hot flashes; vomiting; loss of appetite; weakness; cough; shortness of breath; constipation; increased liver enzymes; diarrhea.
Tell your health care provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects with FASLODEX. For more information, ask your health care provider or pharmacist. You may report side effects to FDA at 1-800-FDA-1088.
Approved Uses for FASLODEX
FASLODEX is a prescription medicine used to treat women with:
- Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer, who have gone through menopause and have not been previously treated with endocrine therapy
- HR-positive advanced breast cancer, who have gone through menopause and whose disease has progressed after endocrine therapy
- HR-positive, HER2‐negative advanced breast cancer or breast cancer that has spread to other parts of the body (metastatic), in combination with palbociclib in women whose disease has progressed after endocrine therapy
When FASLODEX is used in combination with palbociclib, please also see the palbociclib Patient Information.
It is not known if FASLODEX is safe and effective in children or in people with severe liver problems.
Please see FASLODEX Prescribing Information with Patient Information.
IMPORTANT SAFETY INFORMATION ABOUT ARIMIDEX
- Prescription ARIMIDEX is only for postmenopausal women. ARIMIDEX should not be taken if you are pregnant because it may harm your unborn child. Do not take ARIMIDEX if you are allergic to any of its ingredients
- Based on information from a study in patients with early breast cancer, women with a history of blockages in heart arteries (ischemic heart disease) who take ARIMIDEX may have a slight increase in this type of heart disease compared to similar patients who take tamoxifen
- ARIMIDEX can cause bone softening/weakening (osteoporosis) increasing the chance of fractures. In a clinical study in early breast cancer, there were more fractures (including fractures of the spine, hip, and wrist) with ARIMIDEX (10%) than with tamoxifen (7%)
- In a clinical study in early breast cancer, some patients taking ARIMIDEX had an increase in cholesterol. Skin reactions, allergic reactions, and changes in blood tests of liver function have also been reported
- In the early breast cancer clinical trial, the most common side effects seen with ARIMIDEX include hot flashes, joint symptoms (including arthritis and arthralgia), weakness, mood changes, pain, back pain, sore throat, nausea and vomiting, rash, depression, high blood pressure, osteoporosis, fractures, swelling of arms/legs, insomnia, and headache
- In advanced breast cancer trials, the most common side effects seen with ARIMIDEX versus tamoxifen include hot flashes, nausea, decreased energy and weakness, pain, back pain, headache, bone pain, increased cough, shortness of breath, sore throat, and swelling of arms and legs. Joint pain/stiffness has been reported in association with the use of ARIMIDEX
- ARIMIDEX should not be taken with tamoxifen or estrogen-containing therapies
Approved Uses for ARIMIDEX
ARIMIDEX is approved for adjuvant treatment (treatment following surgery with or without radiation) of postmenopausal women with hormone receptor-positive early breast cancer.
ARIMIDEX is approved for the initial treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer and for the treatment of postmenopausal women with advanced breast cancer that has progressed following treatment with tamoxifen. Patients with hormone receptor-negative disease and patients who did not previously respond to tamoxifen therapy rarely responded to ARIMIDEX.
For more information, see your doctor.
Please see full Prescribing Information.
