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

Mary L Windle, PharmD

Disclosures

January 11, 2018

In This Article

Alunbrig (brigatinib)

Indication:

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

Mechanism:

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.

Dosage:

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:

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.

Reference:

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.

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