Caprelsa vandetanib regulatory update

Germany's Federal Joint Committee (G-BA) said in a final benefit assessment that Caprelsa vandetanib from AstraZeneca has "marginal" additional benefit over best supportive care for aggressive, symptomatic medullary thyroid cancer (MTC) that is unresectable, locally advanced or metastatic - the drug's approved indication. In a June preliminary assessment, Germany's Institute for Quality and Efficiency in Healthcare (IQWiG) said Caprelsa provides "no additional benefit" over best supportive care because of "uncertainty" with adverse event data for the drug, which IQWiG said meant it "cannot be ruled out" that Caprelsa's negative effects outweigh its benefits. AstraZeneca submitted additional adverse event data for Caprelsa and data on severity of pain after IQWiG's assessment (see BioCentury, June 24). ...