Japan first to approve Roche’s lung cancer drug alectinib

The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Swiss pharma major Roche’s (ROG: SOX) 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, the first for this new product, was based on results from a Japanese Phase I/II clinical study (AF-001JP) for people whose tumors were advanced, recurrent or could not be removed completely through surgery (unresectable).

“The approval of alectinib, a treatment specifically targeted to ALK+ lung cancer, in Japan is great news for people living with this difficult to treat disease,” said Sandra Horning, Roche’s chief medical officer and head of global product development. “Another interesting aspect of alectinib is that based on early studies it may also work in people living with tumors that have spread to the brain, a difficult area to reach with current medicines. Our research will continue in this area," she added.

Launch expected later this year

Alectinib is expected to be made available in Japan later this year. Alectinib was also granted Breakthrough Therapy designation by the US Food and Drug Administration in June 2013 for patients with ALK+ NSCLC who progressed on crizotinib.

Global pivotal studies are currently ongoing which will further inform on the clinical value of alectinib in this disease setting as well as in treatment-naïve patients. The results of these studies will be used in future regulatory submissions in the US and in Europe.