Astra Zeneca’s thyroid cancer drug Calpresa gets the green light by the EMA
London – The European Medicines Agencies (EMA) has paved the way for the market authorisation of AstraZeneca’s oral thyroid cancer drug Caprelsa (vandetanib, L01EX). On Friday, the regulators said that the oral multi protein kinase blocker clearly improves progression-free survival in patients suffering from metastatic or unresectable, locally advanced medullary thyroid cancer. However, the agency also recommended narrowing the application of the inhibitor of the angiogenetic protein VEGF, EGFR and the proto-oncogene RET, to patients that carry a RET mutation. According to the EMA’s CHMP, in patients where the RET mutation status is not known or negative „a possible lower benefit should be taken into account“. AstraZeneca said that it has already provided data demonstrating that non-RET patients benefit from its treatment. But it will add data from an additional trial. Caprelsa already gained US approval in April. Initially, AstraZeneca tried to get approval for the drug in non-small cell lung cancer but proof-of-efficacy failed in clinical trials. The niche indication medullary thyroid cancer is the least common of the four types of thyroid cancer.