FDA Approved Drugs » 2010
Medical Areas: Obstetrics/Gynecology (Women’s Health) | Oncology | Family Medicine
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved November 2010
Treatment Area: metastatic breast cancer
Halaven (eribulin mesylate) is a non-taxane microtubule dynamics inhibitor. It is a synthetic analogue of halichondrin B, a product isolated from the marine sponge Halichondria okadai.
Halaven is specifically indicated for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease.
Halaven is supplied as a solution for intravenous injection.The recommended dose is 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.The recommended dose of Halaven in patients with mild hepatic impairment (Child-Pugh A) is 1.1 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.The recommended dose of Halaven in patients with moderate hepatic impairment (Child-Pugh B) is 0.7 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.The recommended dose of Halaven in patients with moderate renal impairment (creatinine clearance of 30-50 mL/min) is 1.1 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.
FDA ApprovalThe FDA approval of Halaven was based on an open-label, randomized, multicenter trial in 762 patients with metastatic breast cancer who received at least two chemotherapeutic regimens and experienced disease progression within six months of their last chemotherapeutic regimen. The subjects were randomized to receive Halaven (n=508) or a single agent therapy selected prior to randomization (n=254). Randomization was stratified by geographic region, HER2/neu status, and prior capecitabine exposure. Halaven was administered at a dose of 1.4 mg/m2 on Days 1 and 8 of a 21-day cycle. Halaven-treated patients received a median of 5 cycles of therapy. Control arm therapy consisted of 97% chemotherapy and 3% hormone therapy. The main efficacy outcome was overall survival. A statistically significant improvement in overall survival was observed n the Halaven arm vs. placebo: of the 508 subjects in the Halaven arm there were 274 deaths and of the 254 subjects in the control arm there were 148 deaths (p=0.041). An updated, unplanned survival analysis was conducted when 77% of events had been observed and was consistent with the primary analysis (386 vs. 203 deaths, respectively). The objective response rate in the Halaven arm, measured by the RECIST criteria, was 11% and the median response duration was 4.2 months.
Adverse events associated with the use of Halaven may include, but are not limited to, the following:
Halaven (eribulin mesylate) is a non-taxane microtubule dynamics inhibitor. It is a synthetic analogue of halichondrin B, a product isolated from the marine sponge Halichondria okadai.Eribulin inhibits the growth phase of microtubules without affecting the shortening phase and sequesters tubulin into nonproductive aggregates. Eribulin exerts its effects via a tubulin-based antimitotic mechanism leading to G2/M cell-cycle block, disruption of mitotic spindles, and, ultimately, apoptotic cell death after prolonged mitotic blockage.
Cortes J, Vahdat L, Blum JL, Twelves C, Campone M, Roché H, Bachelot T, Awada A, Paridaens R, Goncalves A, Shuster DE, Wanders J, Fang F, Gurnani R, Richmond E, Cole PE, Ashworth S, Allison MA Phase II study of the halichondrin B analog eribulin mesylate in patients with locally advanced or metastatic breast cancer previously treated with an anthracycline, a taxane, and capecitabine. Journal of clinical oncology : official journal of the American Society of Clinical Oncology 2010 Sep 1;28(25):3922-8
Twelves C, Cortes J, Vahdat LT, Wanders J, Akerele C, Kaufman PA Phase III trials of eribulin mesylate (E7389) in extensively pretreated patients with locally recurrent or metastatic breast cancer. Clinical Breast Cancer 2010 Apr;10(2):160-3
For additional information regarding Halaven or metastatic breast cancer, please visit the Halaven web page.
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