Alectinib was approved in Japan in July 2014 for the treatment of ALK fusion-gene positive, unresectable, advanced or recurrent non-small-cell lung cancer (NSCLC).
It was granted an accelerated approval by the US Food and Drug Administration (FDA) in December 2015 to treat patients with advanced ALK-positive NSCLC whose disease worsened after, or who could not tolerate, treatment with crizotinib (Xalkori). (This was converted into a full approval in Nov 2017).
In November 2017 the FDA approved alectinib for the first-line treatment of patients with ALK-positive metastatic non-small cell lung cancer. This based on the phase 3 ALEX trial comparing it with crizotinib.
DOSAGE FORMS AND STRENGTHS
Capsules: 150 mg