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The tests will be developed to identify NSCLC patients with ALK fusions and EGFR Exon20 insertion mutations who respond to mobocertinib or brigatinib.
The approval was based on data showing superior efficacy for Alunbrig compared to Pfizer's Xalkori, especially in patients with brain metastasis.
At AACR's annual meeting, a researcher described how the breakthrough therapy designated drug was designed specifically to overcome the challenges of targeting EGFR exon 20 insertions.
The approval presents another treatment option for the 3 percent to 5 percent of metastatic NSCLC patients with ALK rearrangements.
The European Commission will now consider whether to grant marketing authorization to the drug regimen.
The positive committee opinion is based on data from the Phase III ALTA-1L trial, which is also supporting the drug's US application for a first-line indication.
The company is seeking to expand the use of the drug as a first-line treatment after it received accelerated approval from the FDA in 2017 for those who failed on Xalkori.