FDA New Drug and Biologic Approvals -- 2017 Year-in-Review

Mary L Windle, PharmD


January 11, 2018

In This Article

Alunbrig (brigatinib)


Anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) in patients who have progressed on or are intolerant to crizotinib.


Tyrosine kinase inhibitor with in vitro activity at clinically achievable concentrations against multiple kinases, including ALK, ROS1, insulinlike growth factor-1 receptor (IGF-1R), and FLT-3, as well as EGFR deletion and point mutations.


90 mg PO once daily for the first 7 days. If 90 mg/day is tolerated, increase the dose to 180 mg PO once daily. Administer until disease progression or unacceptable toxicity.


Approval was based on a noncomparative, two-arm, open-label, multicenter ALTA clinical trial (n=222). After a median follow-up of 8 months, median duration of response was 13.8 months.


Kim DW, et al. Brigatinib in patients with crizotinib-refractory anaplastic lymphoma kinase-positive non-small-cell lung cancer: A Randomized, Multicenter Phase II Trial. J Clin Oncol. 2017 May 5.


Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.