Brigatinib indication expanded in USA
medwireNews: Brigatinib has become the latest ALK–tyrosine kinase inhibitor (TKI) to be approved by the US FDA for use in patients with ALK inhibitor-naïve metastatic non-small-cell lung cancer (NSCLC) harboring ALK rearrangements.
The presence of ALK alterations needs to be confirmed with the Vysis ALK Break Apart FISH Probe Kit (Abbott Molecular, Inc, Abbott Park, Illinois, USA), which has been approved as a companion diagnostic test.
The ALK–TKI had previously been approved for patients who had received prior crizotinib for ALK-altered NSCLC.
The current decision follows on from the phase 3 ALTA 1L trial that showed significantly better progression-free survival with brigatinib versus crizotinib in individuals who had not received prior ALK inhibitor therapy for ALK-positive advanced NSCLC.
As per the prescribing information, brigatinib should be given at a daily dose of 90 mg for the first week, after which the dose should be increased to 180 mg/day. The drug can be taken with or without food.
Speaking to medwireNews, lead author of the ALTA 1L trial D Ross Camidge (University of Colorado Cancer Center, Aurora, USA) said that “brigatinib now joins alectinib as a highly efficacious next generation ALK–TKI superior to crizotinib in the first line setting.”
He added that “the efficacy of alectinib and brigatinib are identical in this first line setting when comparing ALTA-1L with ALEX,” but there are differences in pill burden and side effect profiles, “hence it is good to have two alternatives for patients.”
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