FDA Approves New Indication for FASLODEX® (fulvestrant)

Approval Expands Use and Offers Additional Option for Women with HR+, HER2- Metastatic Breast Cancer

WILMINGTON, Del.--()--AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved a new indication expanding the use of FASLODEX® (fulvestrant) to include use in combination with palbociclib. The combination use is for the treatment of women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer (MBC) whose cancer has progressed after endocrine therapy.1 FASLODEX has been approved since 2002 as a monotherapy for the treatment of postmenopausal women with HR+ MBC whose cancer has progressed following antiestrogen therapy.

Estrogen receptor (ER) positive breast cancer is the most common subtype of breast cancer and one of the key drivers of disease progression for this subtype is through the ER. Laboratory studies show that FASLODEX directly targets the ER by blocking and degrading the ER, helping to inhibit tumor growth.1,2

“The new FASLODEX indication provides another important treatment option for patients, as described in the study, who progressed on or early after prior endocrine therapy. The data supporting combination therapy with FASLODEX plus palbociclib showed a clear increase in progression-free survival in patients in the combination arm, as compared to FASLODEX and placebo,” said Dr. Dennis Slamon, Professor of Medicine, Chief of the Division of Hematology/Oncology and Executive Vice Chair for Research for UCLA's Department of Medicine.

The FDA approval of this new indication for FASLODEX is based on data from the Phase III PALOMA-3 trial, which met the study’s primary endpoint of progression-free survival (PFS). The combination of FASLODEX 500 mg and palbociclib 125 mg resulted in a 4.9 month PFS improvement over FASLODEX and placebo, in women with HR+ HER2- advanced or MBC whose disease had progressed after endocrine therapy. Improvement in PFS was seen irrespective of menopausal status.1

The most common adverse reactions (≥10%) of any grade reported in PALOMA-3 of FASLODEX plus palbociclib vs FASLODEX plus placebo included neutropenia (83% vs 4%), leukopenia (53% vs 5%), infections (47% vs 31%), fatigue (41% vs 29%), nausea (34% vs 28%), anemia (30% vs 13%), stomatitis (28% vs 13%), headache (26% vs 20%), diarrhea (24% vs 19%), thrombocytopenia (23% vs 0%), constipation (20% vs 16%), vomiting (19% vs 15%), alopecia (18% vs 6%), rash (17% vs 6%), decreased appetite (16% vs 8%), and pyrexia (13% vs 5%).1 For more information, please see Important Safety Information for FASLODEX below.

“We believe that advances in cancer treatment will come, in part, from our research building upon existing treatments. This new indication adds to the existing body of evidence supporting FASLODEX-based therapy for certain metastatic breast cancer patients in an area where there is still a high unmet medical need,” said Andrew Coop, Vice President, US Medical Affairs, Oncology at AstraZeneca.



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 in patients on anticoagulants.

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).

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 last dose. Advise lactating women not to breast-feed during treatment with FASLODEX and for 1 year after the final dose because of the potential risk to the infant.

Adverse Reactions


The most common adverse reactions occurring in ≥5% of patients receiving 500 mg 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 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%). A causal relationship between these events and FASLODEX alone has not been established.

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

Indications for FASLODEX


FASLODEX is indicated for the treatment of hormone receptor (HR)-positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy.

Combination Therapy

FASLODEX in combination with palbociclib is indicated for the treatment of HR-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in women with disease progression after endocrine therapy.

The full Prescribing Information for FASLODEX is available here.


About PALOMA-3

PALOMA-3 is a Phase III international, randomized, double-blind, parallel group, multicenter study of FASLODEX plus palbociclib versus FASLODEX plus placebo conducted in women with HR+/HER2- advanced or metastatic breast cancer, regardless of their menopausal status, whose disease progressed on or after endocrine therapy. The study evaluated 521 pre/postmenopausal women who were randomized 2:1 to FASLODEX plus palbociclib or FASLODEX plus placebo. Women, who were either premenopausal (meaning they had not reached menopause), or perimenopausal (meaning that their bodies were making the natural transition toward menopause), were therapeutically induced to become postmenopausal and represented 20.7% of the study population.1

Patients enrolled in this study had a median age of 57 years (range 29 to 88). The majority of patients in the study were white (74%). All patients had an ECOG (Eastern Cooperative Oncology Group) PS of 0 or 1, and 80% were postmenopausal. All patients had received prior systemic therapy and 75% of patients had received a previous chemotherapy regimen. Twenty-five percent of patients had received no prior therapy in the metastatic disease setting, 60% had visceral metastases, and 23% had bone only disease.1

FASLODEX 500 mg was given as two 5 mL injections, one in each buttock, on days 1, 15, 29 and once monthly (28 ± 3 days) thereafter. Palbociclib was given orally at a dose of 125 mg daily for 21 consecutive days followed by 7 days off treatment. Patients continued to receive their assigned treatment until objective disease progression, symptomatic deterioration, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.1

About Metastatic Breast Cancer (MBC)

MBC is the most advanced stage of breast cancer (stage four), 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 metastatic breast cancer, the goal of current treatment is to delay disease progression.3

It is estimated that in 2016, there will be approximately 151,000 women in the US living with MBC, and this number is projected to increase to approximately 160,000 by the year 2020.4

About FASLODEX® (fulvestrant)

FASLODEX is approved for the treatment of postmenopausal women with HR+ MBC with disease progression following antiestrogen therapy. FASLODEX is also indicated for use in combination with palbociclib for the treatment of women with HR+, HER2- advanced or MBC whose disease progressed after endocrine therapy.1

FASLODEX represents a hormonal therapy approach that targets the ER. The ER is a key driver of disease progression. FASLODEX helps to slow tumor growth by blocking and degrading the ER.1,2

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 Oncology as one of AstraZeneca’s six 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, the genetic drivers of cancer and resistance, DNA damage repair 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, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three main therapy areas - respiratory, inflammation, autoimmune disease (RIA), cardiovascular and metabolic disease (CVMD) and oncology – as well as in infection and neuroscience. 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.



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

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


National Cancer Institute. What Is Cancer?: Metastatic Cancer. Available Online. Last accessed 2/11/2016.


CancerMPaact.Khapps.com. Breast-United States (Active Disease/Stage IV). Updated November 30, 2015. Available Online. Last accessed 3/2/2016.


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Abigail Bozarth, +1 302-885-2677


Abigail Bozarth, +1 302-885-2677