Roche Wins EU Approval of Alecensa

The European Commission granted a conditional marketing authorization for Alecensa as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase-positive advanced non-small cell lung cancer previously treated with crizotinib.

The conditional approval was based on data showing Alecensa shrank tumors by up to 52.2 percent.

The product is already approved for ALK-positive NSCLC in eight countries in the event that crizotinib fails and in Japan for patients whose tumors are advanced, recurrent or cannot be removed completely through surgery.