Posted by Michael Wonder on 29 Apr 2017
Takeda announces FDA accelerated approval of Alunbrig (brigatinib)
29 April 2017 - Alunbrig approved for ALK+ metastatic non-small-cell lung cancer patients who have progressed on or are intolerant to crizotinib.
Takeda today announced that Alunbrig (brigatinib) has received accelerated approval from the U.S. FDA for the treatment of patients with anaplastic lymphoma kinase-positive 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.
Alunbrig, which previously received breakthrough therapy designation from the FDA, is a once-daily oral therapy that may be taken with or without food.
