This story has been updated with additional details on the FDA approved companion test for Alunbrig and about how patients were genetically tested in the ALTA 1L study.
NEW YORK – The US Food and Drug Administration on Friday approved Takeda Pharmaceutical's brigatinib (Alunbrig) as a treatment for ALK-positive, metastatic non-small cell lung cancer.
The agency simultaneoulsy approved Abbott Molecular's Vysis ALK Break Apart FISH Probe Kit to identify patients with ALK rearrangements who are likely to benefit from brigatinib.