IQWiG again rebuffs Caprelsa

Germany's Institute for Quality and Efficiency in Healthcare (IQWiG) said thyroid cancer drug Caprelsa vandetanib from AstraZeneca plc (LSE:AZN; NYSE:AZN) provides "no additional benefit" over best supportive care, the comparator requested by Germany's Federal Joint Committee (G-BA). IQWiG said in a reassessment that AstraZeneca did not account for a difference in treatment duration between Caprelsa and the comparator, leading to "uncertainty" in the adverse event data. As a result, IQWiG said it "cannot be ruled out" that negative effects of Caprelsa outweigh its benefits to treat aggressive, symptomatic medullary thyroid cancer (MTC) that is unresectable and locally advanced or metastatic -- the drug's approved indication. According to IQWiG's assessment, the European Commission approved Caprelsa for a limited population to establish a positive benefit/risk profile.

AstraZeneca has until July 8 to respond to the assessment; a final assessment from G-BA is expected in early September. ...