Roche says that the Japanese Ministry of Health, Labour and Welfare has approved alectinib for a specific form of advanced lung cancer, the first country to give the compound the green light.

The thumbs-up is for the treatment of people living with non-small cell lung cancer that is anaplastic lymphoma kinase fusion gene-positive (ALK+). The approval was based on results from a Phase I/II study which showed that over 90% of Japanese people in the study responded to treatment with alectinib.

The Japanese approval comes just over a year after the US Food and Drug Administration granted alectinib breakthrough therapy designation for patients with ALK+ NSCLC who progressed on Pfizer’s Xalkori (crizotinib).

Sandra Horning, Roche’s Chief Medical Officer, said the approval “is great news for people living with this difficult-to-treat disease”. She added that “another interesting aspect of alectinib is that based on early studies it may also work in people living with tumours that have spread to the brain, a difficult area to reach with current medicines. Our research will continue in this area”.