FDA approves Alunbrig for ALK+ metastatic non-small cell lung cancer.- Takeda

Takeda Pharmaceutical announced that the FDA has approved Alunbrig (brigatinib) for adult patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. This approval expands Alunbrig’s current indication to include the first-line setting. Alunbrig is a potent and selective next-generation tyrosine kinase inhibitor (TKI) designed to target ALK molecular alterations.

The approval is based on results from the Phase III ALTA 1L trial, which is evaluating the safety and efficacy of Alunbrig compared to crizotinib in adult patients with ALK+ locally advanced or metastatic NSCLC who have not received prior treatment with an ALK inhibitor. After more than two years of follow-up, results from the ALTA 1L trial showed Alunbrig demonstrated superiority over crizotinib, with significant anti-tumor activity observed, especially in patients with baseline brain metastases. Alunbrig reduced the risk of disease progression or death twofold compared with crizotinib (PFS hazard ratio = 0.49), with a 24-month median progression-free survival (PFS) as assessed by a blinded independent review committee (BIRC) versus 11 months for crizotinib. It demonstrated a confirmed overall response rate (ORR) of 74% (95% CI: 66–81) for Alunbrig and 62% (95% CI: 53–70) for crizotinib as assessed by a BIRC. Alunbrig demonstrated a confirmed intracranial ORR for patients with measurable brain metastases at baseline of 78% (95% CI: 52–94) for patients treated with Alunbrig and 26% (95% CI: 10–48) for patients treated with crizotinib.