FDA grants accelerated approval for Alunbrig to treat NSCLC

Alunbrig (brigatinib) has received accelerated approval from the US Food and Drug Administration for the treatment of patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib, reported Japan’s largest drugmaker Takeda Pharmaceutical (TYO: 4502).

The accelerated approval of brigatinib is contingent on results from a confirmatory trial. The Phase III ALTA-1L study has been initiated to compare brigatinib with crizotinib as a frontline therapy for patients with ALK-positive NSCLC.

Alunbrig is a targeted cancer medicine discovered by Ariad Pharmaceuticals, which was acquired by Takeda in February 2017 in a $5.2 billion transaction. Alunbrig received Breakthrough Therapy designation from the FDA for the treatment of patients with ALK+ NSCLC whose tumors are resistant to crizotinib, and was granted Orphan Drug designation by the FDA for the treatment of ALK+ NSCLC, ROS1+ and EGFR+ NSCLC. A Marketing Authorization Application (MAA) for Alunbrig was submitted to the European Medicines Agency in February 2017.