The US FDA has granted approval to Eisai to market Halaven (eribulin mesylate) Injection for the treatment for metastatic, resistant breast cancer.
The FDA's approval of Halaven is contingent upon the patient having already undergone at least two prior chemotherapy regimens that feature standard therapy, including an anthracycline and a taxane,
Approval has been granted based on results from the pivotal Phase III clinical study EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Physician's Choice Versus Eribulin). In this study, patients receiving Halaven survived a median of 2.5 months longer than patients who received a single-agent therapy chosen by their doctor.
CANCER TYPE(S)
Metastatic breast cancer
TREATMENT TYPE(S)
Non-taxane, microtubule dynamics inhibitor
Source
Medical News Today
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