CAPRELSA® (vandetanib)
Tuesday, 21 February 2012
AstraZeneca today announced that the European Commission has granted marketing authorisation for CAPRELSA® (vandetanib) 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.
This European Commission decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on 17 November 2011 and is applicable to all 27 Member States of the European Union.
CAPRELSA, a prescription oral kinase inhibitor treatment, is indicated for the treatment of aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease. For patients in whom Rearranged during Transfection (RET) mutation is not known or is negative, a possible lower benefit should be taken into account before individual treatment decision (see important information in sections 4.4 and 5.1 in the Product Information).
Clinical data show that patients benefit from treatment with CAPRELSA regardless of their RET status. The EC has granted this marketing authorisation which is conditional upon the completion of an observational trial. AstraZeneca will conduct this study to generate additional data to confirm the benefits in patients who are RET negative.
CAPRELSA uses two distinctive mechanisms of action – blocking the blood supply to the tumour by slowing the VEGF (vascular endothelial growth factor receptor) pathway and reducing the growth and survival of the tumour through EGFR (epidermal growth factor receptor) and RET (rearranged during transfection) pathways.
CAPRELSA is a registered trademark of the AstraZeneca group of companies.