EMA panel recommends brigatinib to treat ALK+NSCLCApril 4, 2020
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of brigatinib (Alunbrig) as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor.
Brigatinib is a next-generation tyrosine kinase inhibitor (TKI) that was designed to target and inhibit ALK genetic alterations.
The drug is being evaluated in phase 3 ALTA-1L trial in comparison with crizotinib in patients with ALK+ locally advanced or metastatic NSCLC who have not received prior treatment with an ALK inhibitor.
Results from the trial showed brigatinib demonstrated superiority compared to crizotinib with significant responses observed in patients with baseline brain metastases.
After more than two years of follow-up, brigatinib reduced the risk of intracranial disease progression or death by 69% in patients with brain metastases at baseline (hazard ratio [HR] = 0.31, 95% CI: 0.17–0.56), as assessed by a blinded independent review committee (BIRC), and reduced the risk of disease progression or death by 76% in patients with brain metastases at baseline (HR = 0.24, 95% CI: 0.12–0.45), as assessed by investigators.