Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

FDA Approves Faslodex for Certain Breast Cancers

AstraZeneca news release; 2017 Aug 28

Publish date:: September 5, 2017

The FDA has approved Faslodex (fulvestrant) 500 mg as monotherapy for expanded use in women with certain kinds of breast cancer.

Indications: Faslodex is an estrogen receptor antagonist indicated for the treatment of:

Hormone receptor (HR)-positive, human epidermal growth receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy.
HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy.
HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib in women with disease progression after endocrine therapy.

Dosage and administration: 500 mg administered intramuscularly into the buttocks slowly as two 5 mL injections on days 1, 15, 29 and once monthly thereafter.

Efficacy and safety: Approval is based on results showing improved progression-free survival in those taking Faslodex, compared with patients receiving anastrozole 1 mg.

Side effects/risks: The most common adverse reactions are 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.

Citation:

Faslodex receives US FDA approval as monotherapy for expanded use in breast cancer [news release]. Wilmington, DE: AstraZeneca Pharmaceuticals LP. August 28, 2017. https://www.astrazeneca.com/media-centre/press-releases/2017/faslodex-receives-us-fda-approval-as-monotherapy-for-expanded-use-in-breast-cancer.html. Accessed September 2, 2017.

Faslodex [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP. 2017. https://www.azpicentral.com/faslodex/faslodex.pdf#page=1. Accessed September 2, 2017.

This Week's Must Reads

Phase II Trial of DNA Vaccine Encoding PAP in Patients with PCa ,

Utilization of Surgery for Post-prostatectomy Incontinence,

Claims Analysis of Advanced PCa Treatment Costs and Resource Use,

Testosterone Therapy Doesn't Increase Prostate Cancer Risk,

Clinical Outcomes in Cyclin-dependent Kinase 12 Mutant Advanced PCa,

Must Reads in Breast Cancer

Increased Cancer Death Linked to Radioactive Iodine Therapy,

Bioimpedance Spectroscopy May Better Identify Lymphedema Progression,

Stereotactic Radiotherapy System Approved For BC, FDA news release; 2017 Dec 22

Perjeta Approved for Certain Type of Early BC, Genentech news release; 2017 Dec 20

Cochrane on Bisphosphonates for Breast Cancer, Cochrane; 2017 Oct 30; O'Carrigan, Wong, et al