Over the last 2 years, our therapeutic armamentarium against genomically defined subgroups of non–small cell lung cancer (NSCLC) has extended to patients with acquired resistance to front-line targeted therapy. Alectinib (Alecensa; Roche/Genentech), a second-generation, orally active, potent, and highly selective inhibitor of anaplastic lymphoma kinase (ALK), is indicated for patients with metastatic, ALK rearrangement–positive NSCLC whose disease has worsened after treatment with crizotinib or who became intolerant to the drug. Alectinib received orphan drug designation, breakthrough therapy designation, priority review status, and accelerated approval by the FDA. Clin Cancer Res; 22(21); 1–6. ©2016 AACR.
- Received June 2, 2016.
- Revision received August 8, 2016.
- Accepted August 8, 2016.
- ©2016 American Association for Cancer Research.