UK's NICE rejects Eisai's Halaven for advanced breast cancer

17 November 2011

In a second negative from the UK’s National Institute for Health and Clinical Excellence, in final draft guidance the NICE says it has not been able to recommend Japanese drug major Eisai’s (TYO: 4523) Halaven (eribulin) for the treatment of locally advanced or metastatic breast cancer in people whose disease has progressed after at least two chemotherapeutic regimens for advanced disease.

Commenting on the draft guidance NICE Chief Executive, Sir Andrew Dillon said: “Although the evidence presented to the independent advisory committee indicated that eribulin may help some patients live for a little longer, it also caused more undesirable side effects than other treatments already available, and the effects on health-related quality of life had not been adequately assessed.”

He continued: “The advisory committee heard from clinical experts that in current practice, patients at this stage usually receive sequential treatment of vinorelbine, capecitabine and, more rarely, gemcitabine. The experts also stressed that even if eribulin were approved by NICE, it would be unlikely to replace capecitabine and vinorelbine in the established sequential pathway because of its related side effects.”

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