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Vandetanib in thyroid cancer: Added benefit not proven
Date:8/2/2013

Vandetanib (trade name: Caprelsa) has been approved in Germany since February 2012 for the treatment of adult patients who have a particular form of aggressive thyroid cancer. In a new benefit assessment, the German Institute for Quality and Efficiency in Health Care (IQWiG) has now examined the added benefit of the drug pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG).

There is a hint that pain occurs later or gets worse later in a part of the patients, the ones aged under 65 years.But because of the overall poor data on side effects, no conclusion could be drawn about harm. Therefore it was not possible to balance positive and negative effects. Overall, an added benefit of vandetanib is therefore not proven.

Contents of the first dossier on vandetanib were incomplete

Vandetanib underwent a first early benefit assessment procedure in 2012. In this procedure, the drug manufacturer did not present any data for the patients for whom the drug is approved. The added benefit was regarded as not proven because the contents of the dossier were incomplete. The pharmaceutical company could apply for a reassessment of vandetanib within a transition period and submit a new dossier to the Federal Joint Committee (G-BA).

"Best supportive care" as the appropriate comparator therapy

In the newly submitted dossier, the company now presented an analysis of data for patients who were treated according to the approval status. As specified by the G-BA, vandetanib was compared with "best supportive care". This means the best possible supportive therapy, optimized for the individual patient for alleviation of symptoms and improvement in the quality of life.

The only study relevant for the benefit assessment, the approval study, compared the administration of vandetanib in combination with "best supportive care" with a treatment consisting of "best supportive care" in combination with
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Contact: Press Contact
presse@iqwig.de
49-022-135-6850
Institute for Quality and Efficiency in Health Care
Source:Eurekalert

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