In a third rejection, the UK drug watchdog the National Institute for Health and clinical Excellence (NICE) has issued new guidance not recommending Halaven (eribulin), from Japanese drug major Eisai (TYO: 4523), 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 (The Pharma Letter November 17, 2011).
Commenting on the final 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 committee felt that eribulin’s effects on health-related quality of life had not been adequately assessed.”
He added: “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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