Eisai receives positive EU stance on breast cancer drug

Eisai has been granted a positive opinion from European healthcare regulators on the approval of its new metastatic breast cancer drug Halaven.

The European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) has recommended the treatment as a monotherapy for patients who have previously received at least two chemotherapeutic regimens.

Halaven has already been approved in this specification in the US and has been endorsed for priority review status by the UK's National Institute for Health and Clinical Excellence (NICE).

The CHMP's backing was granted on the basis of positive data from a phase III clinical study, which demonstrated the drug's overall survival benefits.

A statement from the manufacturer said: "Eisai believes that the CHMP positive opinion further supports Halaven's role in treating locally advanced and metastatic breast cancer and draws the company closer to making this important treatment available to patients."

Last week, Eisai welcomed news that NICE is to approve its Alzheimer's drug Aricept for use among patients with mild to moderate symptoms.