Posted by Michael Wonder on 04 Oct 2017
Takeda announces FDA approval of Alunbrig (brigatinib) 180 mg tablets
3 October 2017 - New dosing option will reduce pill burden for patients living with ALK positive non-small-cell lung cancer.
Takeda today announced that the U.S. FDA has approved the supplemental new drug application for Alunbrig (brigatinib) 180 mg tablets. Alunbrig received accelerated approval from the FDA in April 2017 for the treatment of patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small-cell lung cancer who have progressed on or are intolerant to crizotinib.
This indication is approved under Accelerated Approval based on tumour response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. The recommended dosing regimen for Alunbrig is 90 mg orally once daily for the first seven days and if tolerated, the dose is then increased to 180 mg orally once daily.
