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Added benefit of eribulin in breast cancer is not proven
Date:8/16/2012

Eribulin (trade name: Halaven) was approved in March 2011 for women with locally advanced or metastasizing breast cancer in whom the disease has progressed despite prior drug therapy.

In an early benefit assessment pursuant to the "Act on the Reform of the Market for Medicinal Products" (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether eribulin offers an added benefit compared with the present standard therapy.

According to the results of the assessment, the currently available evidence provides "hints" that eribulin may increase survival time in patients for whom taxanes or anthracyclines are no longer an option. However, it is unclear how many more weeks or months patients can survive. No survival advantage was shown in patients who can still be treated with taxanes or anthracyclines. At the same time, due to a lack of suitable data it cannot be excluded with sufficient certainty that eribulin causes greater harm in the form of side effects. Overall, IQWiG therefore concludes that an added benefit of eribulin is not proven.

G-BA specifies appropriate comparator therapy

According to the legal ordinance, benefit assessments must follow the approval status. This refers both to the new drug to be evaluated and to the therapies used in the comparator groups.

Eribulin is approved for patients in whom the disease has progressed further, despite having received at least two cycles of a taxane and anthracycline containing chemotherapy (unless these treatments were considered unsuitable). As appropriate comparator therapies, the Federal Joint Committee (G-BA) has specified either monotherapy with capecitabine, 5-fluorouracil, or vinorelbine or renewed therapy with taxanes or anthracyclines, insofar as this is an option for patients.

The pharmaceutical company followed this specification of the appropriate comparator therapy. However, by the wording of the res
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Contact: Anna-Sabine Ernst
presse@iqwig.de
49-022-135-6850
Institute for Quality and Efficiency in Health Care
Source:Eurekalert

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