20% reduction in disease progression vs ARIMIDEX® (anastrozole), a current standard treatment option

Expanded approval supports initial use for advanced breast cancer patients not previously treated with endocrine therapy

AstraZeneca today 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%)
  • The most common adverse reactions (≥10%) of any grade reported in patients receiving FASLODEX 500 mg plus palbociclib 125 mg/day were: neutropenia, leukopenia, infections, fatigue, nausea, anemia, stomatitis, headache, diarrhea, thrombocytopenia, constipation, vomiting, alopecia, rash, decreased appetite, and pyrexia

Indications for FASLODEX

Monotherapy

FASLODEX is an estrogen receptor antagonist indicated for the:

  • Treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy
  • Treatment of HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy

Combination Therapy

  • FASLODEX in combination with palbociclib is indicated for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer in women with disease progression after endocrine therapy

Please see full 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.

NOTES TO EDITORS

About FALCON

The FALCON (Fulvestrant and AnastrozoLe COmpared in endocrine therapy Naïve advanced breast cancer) trial is a Phase III, randomized, double-blind, multicenter trial comparing the efficacy and tolerability profile of a 500mg dose of FASLODEX plus placebo with a 1mg dose of ARIMIDEX plus placebo, in postmenopausal women with HR+, locally-advanced or metastatic breast cancer, who have not had prior endocrine therapy.2

The FALCON trial was designed, based on positive results from the Phase II FIRST trial, which demonstrated a greater median overall survival nearly six months longer with FASLODEX, when compared to ARIMIDEX.8

About Advanced Breast Cancer or Metastatic Breast Cancer (ABC/MBC)

Advanced/metastatic breast cancer refers to Stages III and IV breast cancer. Stage III disease may be referred to as locally-advanced breast cancer. MBC is the most advanced stage of breast cancer (Stage IV), and occurs when cancer cells have spread beyond the initial tumor site to other parts of the body outside of the breast. Since there is no cure for MBC, the goal of current treatment is to delay disease progression or death.9,10,11

It is estimated that in 2017, there will be approximately 153,000 women in the US living with MBC, and this number is projected to increase to approximately 160,000 by the year 2020.12

About FASLODEX

FASLODEX is a medicine for postmenopausal women with hormone receptor-positive (HR+) advanced breast cancer with disease progression following endocrine therapy. When taken with palbociclib, it’s used to treat postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression after endocrine therapy. FASLODEX is indicated for HR+, HER2- advanced breast cancer in postmenopausal women not previously treated with endocrine therapy.1

FASLODEX is a hormonal therapy that targets the estrogen receptor (ER). The ER is a key driver of disease progression. FASLODEX helps to slow tumor growth by blocking and degrading the ER.1,3,4,5

About AstraZeneca in Oncology

AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly-growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least six new medicines to be launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, we are committed to advance New Oncology as one of AstraZeneca’s five Growth Platforms focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy as illustrated by our investment in Acerta Pharma in hematology.

By harnessing the power of four scientific platforms – Immuno-Oncology, Tumor Drivers and Resistance, DNA Damage Response and Antibody-Drug Conjugates – and by championing the development of personalized combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three main therapy areas – Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of Autoimmunity, Neuroscience and Infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca-us.com and follow us on Twitter @AstraZenecaUS.

References

1. FASLODEX Full Prescribing Information. AstraZeneca Pharmaceuticals LP Wilmington, DE.

2. Robertson JFR, Bondarenko IM, Trishkina E, et al,. Results from the Phase III, randomised, double-blind, Fulvestrant 500 mg versus anastrozole 1 mg for hormone receptor-positive advanced breast cancer (FALCON): a randomised, double-blind, Phase 3 trial. Lancet 2016. 388(10063):2997-3005.

3. Howell A. Is fulvestrant (“FASLODEX”) just another selective estrogen receptor modulator? Int J Gynecol Cancer. 2006;16(2):521-523.

4. National Cancer Institute. Hormone Therapy for Breast Cancer Fact Sheet. Available Online. Accessed August 2017.

5. Mehta RS, Barlow WE, Albain KS, et al. Combination anastrozole and fulvestrant in metastatic breast cancer. N Engl J Med. 2012 Aug 2;367(5):435-44.

6. AstraZeneca Press Release. FDA approves new indication for FASLODEX® (fulvestrant). Available Online. Accessed August 2017.

7. FDA Approval Letter. U.S. Food and Drug Administration, Silver Spring, MD Accessed August 2017.

8. Ellis MJ, et al. Fulvestrant 500 mg Versus Anastrozole 1 mg for the First-Line Treatment of Advanced Breast Cancer: Overall Survival Analysis From the Phase II FIRST Study. J Clin Oncol. 2015 Nov 10;33(32):3781-7. Accessed August 2017.

9. Cleveland Clinic. Diseases and Conditions: Breast Cancer. Available Online. Last Updated September 5, 2013. Accessed August 2017.

10. Mayo Clinic. Breast Cancer Diagnosis. Available Online. Last Updated August 16, 2016. Accessed August 2017.

11. American Cancer Society. What Is Advanced Cancer? Atlanta: American Cancer Society; 2014. Available online. Accessed August 2017.

12. CancerMPact.Khapps.com: ONC-Prevalence of Metastatic Breast Cancer in Women 2014-2020. Accessed August 2017.

US-11572 Last Updated 8/17

AstraZenecaMichele Meixell, +1-302-885-2677orAlexandra Engel, +1-302-885-2677

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