FDA approves new dose of FASLODEX in the fight against metastatic breast cancer

(ARA) – For the approximately 155,000 women in the US who are currently living with metastatic breast cancer,1 an effective treatment option may offer more disease control. The US Food and Drug Administration (FDA) recently approved a new dose of a medicine called FASLODEX® (fulvestrant) Injection for postmenopausal women with hormone receptor-positive breast cancer whose disease has spread after treatment with antiestrogren medicine. FDA approval is based on a clinical study that showed FASLODEX 500 mg delayed breast cancer progression by 20 percent compared to the previously approved 250-mg dose and had a comparable safety profile.2

“For women with metastatic breast cancer, the treatment approach centers on slowing the progression of cancer,” said Gershon Locker, MD, Senior Medical Director AstraZeneca Medical Affairs. “FASLODEX 250 mg has been an option for some patients for some time, and now we know that FASLODEX 500 mg is better at delaying that progression.”2,3

In some breast cancers, the presence of estrogen causes the cancer cells to grow.4 Called hormone receptor positive, this type of cancer may be responsive to medicines called hormonal treatments, which reduce or block the effects of estrogen.5 FASLODEX is a type of hormonal treatment for metastatic breast cancer that works by attaching to estrogen receptors and changing their shape, blocking estrogen from binding to the receptors. In addition, FASLODEX causes a degradation (downregulation) of estrogen receptors.6,7

The study supports the use of FASLODEX (500 mg) to treat hormone receptor-positive metastatic breast cancer in postmenopausal women whose disease has returned or progressed following treatment with prior hormonal therapy. A 250-mg dose modification is recommended for women with moderate liver impairment.2 Women should talk to their doctor for more information about the dosing regimen for FASLODEX.

For information about FASLODEX and support information for women living with metastatic breast cancer, please visit www.faslodex.com.

Important Safety Information About FASLODEX® (fulvestrant) Injection

You should not receive FASLODEX if you have had an allergic reaction to any of the ingredients in FASLODEX. Symptoms of an allergic reaction to FASLODEX may include itching, swelling of your face, lips, tongue, or throat, or trouble breathing.

Because FASLODEX is administered directly into the muscle, you should tell your doctor if you have a blood disorder or are on anticoagulants (sometimes called blood thinners).

Also tell your doctor if you have liver problems.

Tell your doctor if you are pregnant. FASLODEX can harm your unborn baby. Talk to your doctor about how to prevent pregnancy while receiving FASLODEX. Tell your doctor right away if you become pregnant or think you are pregnant while receiving FASLODEX.

The common side effects were: injection site pain, nausea, muscle, joint, and bone pain, headache, tiredness, hot flashes, vomiting, loss of appetite, weakness, cough, constipation, shortness of breath, and increased liver enzymes.

Approved Use For FASLODEX

FASLODEX is a prescription medicine used to treat hormone receptor-positive breast cancer in women who have gone through menopause whose disease has spread after treatment with antiestrogen medicine.

FASLODEX is a registered trademark of the AstraZeneca group of companies.

For more information, visit www.FASLODEX.com.
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1 Data on File. 266478. AZPLP. Wilmington, DE. 2 Di Leo A, Jerusalem G, Petruzelka L, et al. CONFIRM Phase III trial comparing fulvestrant 250 mg with fulvestrant

2 Di Leo A, Jerusalem G, Petruzelka L, et al. CONFIRM Phase III trial comparing fulvestrant 250 mg with fulvestrant 500 mg in postmenopausal women with estrogen receptor-positive advanced breast cancer [published online ahead of print September 20, 2010]. J Clin Oncol. 2010. http://jco.ascopubs.org/cgi/doi/10.1200/JCO.2010.28.8415. Accessed September 21, 2010.

3 Beslija, S, et al. Second consensus on medical treatment of metastatic breast cancer. Annals of Oncology. 2007; 18:215-225.

4 Harrell J, Dye W, Harvell D, Pinto M, et al: Estrogen Insensitivity in a Model of Estrogen Receptor-Positive Breast Cancer Lymph Node Metastasis. Cancer Research, 2007; 67: (21) November 1, 2007.

5 American Cancer Society. Detailed Guide: Breast Cancer. http://www.cancer.org/acs/groups/cid/documents/webcontent/003037-pdf.pdf. Updated September 24, 2010. Accessed June 29, 2010.

6 Carlson, RW. The History and Mechanism of Action of Fulvestrant. Clinical Breast Cancer. 2005; 6(Suppl. 1): S5-S8.

7 Howell, A. Is just another selective estrogen receptor modulator? Int J Gynecol Cancer. 2006; 16(Suppl. 2): 521-523.