FDA Approves Halaven for Late-Stage Breast Cancer

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Good news for patients with late stage metastatic breast cancer.  The US Food and Drug Administration (FDA) approved eribulin mesylate injection (Halaven; Eisai, Inc) for the treatment of metastatic breast cancer in patients who have received at least 2 prior chemotherapy regimens for late-stage disease. 

Eribulin is a synthetic analog of halichondrin B, a novel microtubule dynamics inhibitor extracted from the marine sponge Halichondria okadia. 

FDA approval was based on data from a phase 3 study of 762 women with metastatic breast cancer who had been heavily pretreated with a median of 4 chemotherapy regimens that included an anthracycline and a taxane.  

Patients who have been treated with eribulin has a significantly improved overall survival when compared with patients treated with physician’s choice (13.12 vs 10.65 months; Δ, 2.47 months; hazard ratio, 0.81; P = .041). The 1-year survival rate was 53.9% for eribulin-treated patients and 43.7% for those given other drugs. 

The most common adverse events associated with eribulin include neutropenia, anemia, leukopenia, alopecia, fatigue, nausea, asthenia, peripheral neuropathy, and constipation. 

Other therapeutic options for the treatment of refractory, metastatic breast cancer include capecitabine (Xeloda by Roche) for disease resistant to paclitaxel and anthracycline-based chemotherapy, ixabepilone (Ixempra by Bristol-Myers Squibb Co) for late-stage disease resistant to an anthracycline, taxane, and capecitabine; and a combination of capecitabine and ixabepilone for disease resistant to anthracycline- and taxane-based chemotherapy. 

Please visit healthreason.com for more health related articles.

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