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EXPANDED FIRST-LINE INDICATION PERFORMANCE ALONE Learn more about FASLODEX at FASLODEXhcp.com
Explore the
PALOMA-3 efficacy
and safety data
Explore the
MONARCH 2 efficacy
and safety data
See how FASLODEX
targets the estrogen
receptor1,2-6

Dear Health Care Professional,

FASLODEX was studied in combination with palbociclib in the PALOMA-3 Trial and abemaciclib in the MONARCH 2 Trial, resulting in the approval of both combination regimens for the treatment of
HR-positive, HER2-negative advanced or metastatic breast cancer in women with disease progression after endocrine therapy.1

FASLODEX is the ONLY estrogen receptor-targeting hormonal therapy to be approved in combination with two different CDK4/6 inhibitors, or alone, based on phase 3 trials for the treatment of HR-positive, HER2-negative ABC or mBC.1,7-13

Paloma-3 Monarch-2 Trials

FASLODEX in combination with palbociclib significantly increased PFS vs FASLODEX plus placebo, the control arm: median 9.5 months vs 4.6, respectively1

Extended PFSv Anastrozole v
Investigator-assessed PFS, the primary endpoint of the PALOMA-3 Trial, was evaluated according to RECIST v.1.11
Confirmed overall response rate in patients with measurable disease: 24.6% for the FASLODEX plus palbociclib arm (n=347) and 10.9% for the control arm (n=174)1
 
- Duration of response was 9.3 months in the FASLODEX plus palbociclib arm and 7.6 months in the control arm1
The most frequently reported serious adverse reactions in patients receiving FASLODEX plus palbociclib were infections (3%), pyrexia (1%), neutropenia (1%), and pulmonary embolism (1%)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 pyrexia1

FASLODEX in combination with abemaciclib improved median PFS by 76%:
16.4 months vs 9.3 for FASLODEX plus placebo, the control arm1

Extended PFSv Anastrozole v
Investigator-assessed PFS was the primary endpoint of the MONARCH 2 Trial15
Objective response rate in patients with measurable disease more than doubled in the FASLODEX plus abemaciclib arm (n=318): 48.1% (95% CI: 42.6%-53.6%) and 21.3% (95% CI: 15.1%-27.6%) in the control arm (n=164)1
In the FASLODEX plus abemaciclib arm, complete response was observed in 14 patients (3.1%) and partial response in 143 patients (32.1%). In the control arm, complete and partial responses were observed in 1 patient (0.4%) and 35 patients (15.7%), respectively15
The most frequently reported (≥5%) Grade 3 or 4 adverse reactions in patients receiving FASLODEX plus abemaciclib were neutropenia, diarrhea, leukopenia, anemia, and infections
The most common adverse reactions (≥20%) of any grade reported in patients receiving FASLODEX 500 mg plus abemaciclib 150 mg twice daily were diarrhea, fatigue, neutropenia, nausea, infections, abdominal pain, anemia, leukopenia, decreased appetite, vomiting, and headache1

ABC=advanced breast cancer; CDK4/6=cyclin-dependent kinase 4/6; HER2=human epidermal growth factor receptor 2;
HR=hormone receptor; mBC=metastatic breast cancer; OR=odds ratio; PFS=progression-free survival;
RECIST=Response Evaluation Criteria in Solid Tumors.
*Patients were permitted to have had only 1 prior endocrine therapy for ABC and no prior chemotherapy.15


Extended PFSv Anastrozole v

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 women 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—FASLODEX plus palbociclib
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
Combination Therapy—FASLODEX plus abemaciclib
The most frequently reported (≥5%) Grade 3 or 4 adverse reactions in patients receiving FASLODEX plus abemaciclib were neutropenia, diarrhea, leukopenia, anemia, and infections
The most common adverse reactions (≥20%) of any grade reported in patients receiving FASLODEX 500 mg plus abemaciclib 150 mg twice daily were diarrhea, fatigue, neutropenia, nausea, infections, abdominal pain, anemia, leukopenia, decreased appetite, vomiting, and headache
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 or abemaciclib 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 for FASLODEX with Patient Information.
You may report side effects related to AstraZeneca products by clicking here.

References: 1. FASLODEX® (fulvestrant) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals, LP; 2017. 2. Osborne CK, Schiff R. Mechanisms of endocrine resistance in breast cancer. Annu Rev Med. 2011;62:233-247. 3. Osborne CK, Shou J, Massarweh S, et al. Crosstalk between estrogen receptor and growth factor receptor pathways as a cause for endocrine therapy resistance in breast cancer. Clin Cancer Res. 2005;11(2, pt 2):865s-870s. 4.  Rajbhandari P, Finn G, Solodin NM, et al. Regulation of estrogen receptor α N-terminus conformation and function by peptidyl prolyl isomerase Pin1. Mol Cell Biol. 2012;32(2):445-457. 5. Lamb R, Lehn S, Rogerson L, et al. Cell cycle regulators cyclin D1 and CDK4/6 have estrogen receptor-dependent divergent functions in breast cancer migration and stem cell-like activity. Cell Cycle. 2013;12(15):2384-2394. 6.  Hammond ME, Hayes DF, Dowsett M, et al. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for immunohistochemical testing of estrogen and progesterone receptors in breast cancer (unabridged version). Arch Pathol Lab Med. 2010;134(7):e48-e72. 7. Everolimus [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2016. 8. Prescribing Information for anastrozole. AstraZeneca Pharmaceuticals LP, Wilmington, DE. 9. Palbociclib [prescribing information]. New York, NY: Pfizer Inc; 2016. 10. Letrozole [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2014. 11. Prescribing Information for tamoxifen citrate. AstraZeneca Pharmaceuticals LP, Wilmington, DE. 12. Abemaciclib [prescribing information]. Indianapolis, IN: Eli Lilly and Company; 2017. 13.  Ribociclib [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2017. 14. Cristofanilli M, Turner NC, Bondarenko I, et al. Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial. Lancet Oncol. 2016;17(4):425-439. 15.  Sledge GW Jr, Toi M, Neven P, et al. MONARCH 2: abemaciclib in combination with fulvestrant in women with HR+/HER2- advanced breast cancer who had progressed while receiving endocrine therapy. J Clin Oncol. 2017;35(25):2875-2884.

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US-20363 Last Updated 5/18
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This email was sent to: Amy.Gonsuron@iononline.com

This email was sent by: ION Solutions, An AmerisourceBergen Company
3101 Gaylord Parkway Frisco, TX 75034 USA


We respect your right to privacy - view our policy

This communication is intended to keep ION members current on late breaking events. It may contain confidential information such as pricing, rebate, and other discount arrangements being provided exclusively to ION members, and as such is intended solely for the use of the addressee. If the reader of this message is not the intended recipient, you are hereby notified that any dissemination, copying, distribution or other use of this material is strictly prohibited. In the event that you have received this material in error, or wish to opt-out of any future emails, please Go Here or notify the sender immediately via email or telephone at 866-565-1070 and destroy all copies. Thank you.