Alectinib is approved in Japan for treatment of ALK+ Non Small Cell Lung Cancer-Roche

Roche announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved alectinib for the treatment of people living with Non-Small Cell Lung Cancer (NSCLC) that is anaplastic lymphoma kinase fusion gene-positive (ALK+). The approval was based on results from a Japanese Phase I/II clinical study (AF-001JP) for people whose tumours were advanced, recurrent or could not be removed completely through surgery (unresectable).

Alectinib is expected to be made available in Japan later this year. Alectinib was also granted Breakthrough Therapy Designation (BTD) by the FDA in June 2013 for patients with ALK+ NSCLC who progressed on crizotinib. BTD is designed to expedite the development and review of medicines intended to treat serious diseases and to help ensure patients have access to them through FDA approval as soon as possible.