brigatinib
FDA Approves FoundationOne CDx for Takeda's ALK-Inhibitor
The agency approved Foundation Medicine's tissue-based, next-generation sequencing test to identify patients with ALK-positive NSCLC eligible for Alunbrig.
Foundation Medicine, Takeda Collaborate to Develop CDx for NSCLC Therapies
The tests will be developed to identify NSCLC patients with ALK fusions and EGFR Exon20 insertion mutations who respond to mobocertinib or brigatinib.
Takeda's Alunbrig Gets First-Line FDA Approval With Abbott CDx in ALK-Positive Lung Cancer
The approval was based on data showing superior efficacy for Alunbrig compared to Pfizer's Xalkori, especially in patients with brain metastasis.
Data from the meeting suggest that lung cancer patients with ALK-positive tumors may soon have two first-line options and more choices when their disease progresses.