IQWiG finds Eisai breast cancer drug extends life


The German Institute for Quality and Efficiency in Health Care (IQWiG) has confirmed an additional benefit of Eisai's Halaven (eribulin) in advanced breast cancer, which has shown survival benefits at phase III.

Eribulin is the first in the halichondrin class of microtubule dynamics inhibitors with a novel mechanism of action. It is believed to work by inhibiting the growth phase of microtubule dynamics which prevents cell division.

The drug was tested against comparator therapies for the treatment of women with locally advanced or metastatic breast cancer (MBC) who had progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting, unless patients were not suitable for these treatments.

In its report, IQWiG limited its positive assessment to patients who can no longer be treated with taxanes or anthracyclines. It subsequently defined sub-populations and assessed the extent and probability of an additional benefit. Eisai is critical of some aspects of this approach and will address them in a written statement to the GB-A.

The G-BA is expected to publish its final decision, after considering the IQWiG report, written statements and an oral hearing, at the end of January 2015.

The reassessment for eribulin is based on clinical evidence from two global phase III trials, EMBRACE and Study 301. These studies involved more than 1,800 women. In the total phase III EMBRACE study population, eribulin was shown to prolong median overall survival by 2.7 months in heavily pre-treated women with MBC compared to women receiving the doctor's choice of therapy. In line with the G-BA requirements, additional pooled analyses of data have been specifically performed for the benefit assessment procedure in Germany and reviewed by IQWiG.

"Eribulin is an important and effective treatment option that can and should be given to women earlier in their treatment pathway following this year's indication extension. Eribulin remains the only single-agent chemotherapy proven to extend overall survival in metastatic breast cancer after anthracycline and taxane treatment, and this partially positive assessment by IQWiG will be welcomed by physicians and patients across the country," said Dr Christian Jackisch Professor of Obstetrics and Gynaecology at the Breast Cancer Center Klinikum Offenbach, Germany. "We look forward to the G-BA´s decision and expect it will confirm the experience made in real-world treatment over the last few years and support the earlier use of eribulin."

"We estimate more than 11,000 women in Germany have had the chance to benefit from treatment with Halaven over the past three years and it is good news that the statistically significant and clinically relevant overall survival benefit has been confirmed again to further increase confidence in this innovative treatment option," commented Gary Hendler, president and CEO, Eisai EMEA and president, Eisai Oncology Global Business Unit.

First approved in 2011, eribulin received Marketing Authorisation Approval (MAA) for earlier use in advanced or metastatic breast cancer from the European Commission on 3 July 2014.

Over 300,000 women are diagnosed with breast cancer in Europe every year, of whom about one third subsequently develop metastatic disease, which occurs when cancer spreads beyond the breast to other parts of the body.


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