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Vandetanib in thyroid cancer: No proof of added benefit
Date:11/9/2012

Vandetanib (trade name Caprelsa) has been approved in Germany since February 2012 for adult patients suffering from a particular form of aggressive thyroid cancer. 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). According to the findings, there is no proof of added benefit, because no data on patient-relevant outcomes for those patients for whom the drug is approved were presented by the drug manufacturer in its dossier. In view of these deficiencies, IQWiG considered itself compelled to declare the contents of the dossier as "incomplete".

"Best supportive care" as the appropriate comparator therapy

As specified by the Federal Joint Committee (G-BA), vandetanib should be 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 this benefit assessment compared the administration of vandetanib in combination with "best supportive care" with a treatment consisting of "best supportive care" alone.

Study population differs from approval population

Vandetanib is approved for patients with an "aggressive and symptomatic" medullary thyroid cancer (MTC) in whom surgery is no longer possible, the cancer is already very large or from which secondaries (metastases) have already formed in other regions of the body. The European regulatory authority - the European Medicines Agency (EMA) - had restricted the therapeutic indication in such a way in order to produce an overall positive benefit-risk balance. This is because treatment with vandetanib also involves major risks and can, for example, lead to severe heart rhythm disturbances.

However, in the study presented by the manufacturer, patients in
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Contact: Dr. Anna-Sabine Ernst
presse@iqwig.de
0049-221-356-856
Institute for Quality and Efficiency in Health Care
Source:Eurekalert

Page: 1 2

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