The German Institute for Quality and Efficiency in Health Care (IQWiG) has now examined the added benefit of Anglo-Swedish drug major AstraZeneca’s (LSE: AZN) Caprelsa (vandetanib) under the Act on the Reform of the Market for Medicinal Products (AMNOG), concluding that 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, the IQWiG says it considered itself compelled to declare the contents of the dossier as "incomplete.”
Caprelsa was approved earlier this year by the European Commission for the treatment of aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease. Caprelsa is the first approved treatment for advanced MTC in Europe (The Pharma Letter February 21).
"Best supportive care" as the appropriate comparator therapy
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
7 day trial access
Become a subscriber
Or £77 per month
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze