Halaven approved in Japan but not UK

Eisai's breast cancer treatment Halaven (eribulin) has been approved for use in Japan, while England's National Institute for Health and Clinical Excellence (NICE) has issued draft guidance recommending against use of the drug.

The treatment, Eisai's first novel anticancer agent, can be used in Japan in patients with advanced or metastatic breast cancer.

The approval is based on the phase III EMBRACE study, the data from which indicated patients taking Halaven have an overall extended survival rate of 2.7 months compared to alternative treatments chosen by physicians involved in the trial.

Despite the extended survival rate, NICE, the body that regulates what medicines are used on the NHS in England and Wales, has issued draft guidance recommending against use of the drug in the treatment of breast cancer.

"Although the study indicated that eribulin could potentially help patients live for a little longer," said Sir Andrew Dillon, chief executive, NICE, "it also caused more negative side effects than the other treatments and the effects on health-related quality of life had not been adequately assessed."

According to NICE, experts on the committee that made the recommendation stressed that if eribulin were approved by NICE, it would be unlikely to replace capecitabine and vinorelbine in the treatment pathway for patients with locally advanced or metastatic breast cancer due to its negative side effects.

Nick Burgin, European director of market access, Eisai, said he was "hugely disappointed" with the draft guidance, especially when Eisai had agreed a patient access scheme with the UK's Department of Health (DH).

In December 2010, NICE recommended against the use of Roche's Avastin (bevacizumab) for metastatic breast cancer, citing a lack of evidence for the drug's benefits.

Comments on the draft guidance for Halaven are invited by NICE until August 9, 2011.

There will be a second appraisal meeting on August 25, 2011.