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.
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Cite this: Mary L Windle. FDA New Drug and Biologic Approvals -- 2017 Year-in-Review - Medscape - Jan 11, 2018.