FDA Approves Takeda’s Alunbrig for Non-Small Cell Lung Cancer

The FDA has approved Takeda Pharmaceuticals’ Alunbrig (brigatinib) for adults with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC).

The approval was based on the results of a phase 3 trial in which Alunbrig reduced the risk of disease progression or death twofold compared to crizotinib. The trial also demonstrated an overall response rate of 74 percent for Alunbrig and 62 percent for crizotinib.

The approval expands Alunbrig’s indication to the first-line setting for NSCLC patients. The drug had been previously approved for NSCLC patients who had received crizotinib.