Vandetanib (1) – Caprelsa®

• Clinical trials
  • In its dossier, the pharmaceutical manufacturer submitted the analysis of the results of a randomised, double-blind, multicentre, placebo-controlled trial, D4200C00058, to address the research question (An international, Phase III, randomised, double-blind, placebo-controlled, multi-centre study to assess the efficacy of ZD6474 versus placebo in subjects with unresectable, locally advanced or metastatic medullary thyroid cancer).

aggressive and symptomatic medullary thyroid carcinoma (MTC) in patients with unresectable, locally advanced or metastatic disease

• As the required evidence has not been submitted in full, the additional benefit in relation to the appropriate comparator therapy is deemed not proven (Section 35a(1), fifth sentence, of Book V of the Social Code [SGB V]).
• The G-BA notes that, in the dossier submitted by the pharmaceutical manufacturer for the benefit assessment of vandetanib, the manufacturer has not demonstrated or substantiated, in a manner compliant with statutory and subordinate legal requirements, that vandetanib offers additional benefit over the appropriate comparator therapy specified by the G-BA.
• The dossier must therefore be regarded as incomplete in this respect.
• The pharmaceutical manufacturer did not submit an analysis of the patient population ‘patients with aggressive and symptomatic MTC’ in the dossier.
• In reaching this decision, the G-BA has followed the IQWiG dossier assessment and the expert opinions.

Courtesy translation only, please refer to the German original.