FDA approves Takeda's tyrosine kinase inhibitor ALUNBRIG (brigatinib), first-line treatment of ALK-positive metastatic non-small cell lung cancer patients

Takeda announced that the U.SFood and Drug Administration (FDA) has approved its tyrosine kinase inhibitor (TKI) ALUNBRIG (brigatinib) for metastatic lymphoma kinase-positive (ALK-positive) patients with metastatic non-small cell lung cancer (NSCLC)This approval expands the range of alunBRIG's indications and can be used for first-line treatment of the diseasethis approval is based on the results of a Phase 3 trial of ALTA 1L, which assessed the safety and efficacy of ALUNBRIG compared to a patient of ALK-localized advanced or metastatic NSCLC who were not treated with ALK inhibitorsafter more than two years of follow-up, the results of the ALTA 1L trial showthat that ALUNBRIG is superior to gramtinib and has significant anti-tumor activity, especially in brain metastasis patientscompared to gramtinib, ALUNBRIG tripled the risk of disease progression or death, with a median progression-free survival (PFS) of 24 months, compared with 11 months for cintoniThe overall remission rate (ORR) of ALUNBRIG was 74% and the total remission rate (ORR) was 62%for patients with brain metastasis, THE ORR in ALUNBRIG was 78%, compared with 26% for gramtinibALUNBRIG has previously been designated by the FDA for breakthrough treatment for treating patients who are resistant to gramtinib, and has been awarded the orphan drug designation by the FDA for the treatment of ALK-NSCLC, ROS1-plus and EGFR-NSCLC