The European Commission granted marketing authorization for Chugai Pharmaceutical Co. Ltd.'s Alecensa as a first-line treatment of a certain lung cancer subtype.
Alecensa, or alectinib, is now approved as a monotherapy to treat patients with anaplastic lymphoma kinase-positive, or ALK-positive, metastatic non-small cell lung cancer, or NSCLC.
The approval is based on a phase 3 study which showed that the medicine significantly reduced the risk of disease worsening or death by 47% compared to Pfizer Inc.'s Xalkori, or crizotinib.
The medicine was also switched to full approval from conditional approval as a second-line treatment for patients with ALK-positive, metastatic NSCLC who have progressed on or are intolerant to Xalkori.
Roche Holding AG secured U.S. Food and Drug Administration approval for the first-line indication of Alecensa in November.
Tokyo-listed Chugai is a Roche subsidiary.