FDA approves Eisai breast cancer drug Halaven
pharmafile | November 16, 2010 | News story | Sales and Marketing | Cancer, Eisai, FDA, Halaven, Xeloda, breast cancer, eribulin mesylate, metastatic breast cancer
The FDA has approved Eisai’s advanced breast cancer drug Halaven for use in heavily pre-treated breast cancer patients.
Halaven (eribulin mesylate) was passed by the US regulator for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens.
In addition, prior therapy should have included two common chemotherapy treatments, an anthracycline and a taxane, for early or advanced breast cancer.
The approval is based on successful phase III EMBRACE data, presented earlier this year at the ASCO cancer conference, which showed that Halaven met its primary endpoint by increasing overall survival of 13.25 months over 10.65 months – a median of 2.5 months.
The EMBRACE trial was an open-label, randomised, multi-centre study of 762 patients with locally or recurrent metastatic breast cancer.
Lonnel Coats, president and chief executive, Eisai, said: “The FDA approval of Halaven is significant news for the metastatic breast cancer community in an area of unmet medical need.
“This achievement is consistent with our human healthcare mission of striving to produce therapies that may help make a difference in the lives of patients and their families.”
The drug is a synthetic form of a chemotherapeutically active compound derived from the sea sponge Halichondria okadai.
This injectable therapy is a microtubule inhibitor, believed to work by inhibiting cancer cell growth.
Richard Pazdur, oncology drug director in the FDA’s centre for drug evaluation and research, said: “There are limited treatment options for women with aggressive forms of late stage breast cancer who have already received other therapies.
“Halaven shows a clear survival benefit and is an important new option for women.”
Eisai said it expects to launch Halaven in the US “within 10 business days” and has additionally submitted the drug for regulatory approval in Japan, the EU, Switzerland and Singapore
Current treatments for advanced metastatic breast cancer include Roche’s Xeloda, in combination with docetaxel, after failure of prior anthracycline-containing chemotherapy.
Halaven could potentially be used as an earlier stage of treatment in the future as a second trial is comparing the drug to Xeloda in women as a first or second line treatment.
Ben Adams
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