FDA has approved Alunbrig or Brigatinib for first-line treatment of patients with ALK-positive metastatic non-small cell lung cancer, as detected by FDA-approved test. This approval has been based on phase III ALTA-1L trial. In this trial, treatment with brigatinib demonstrated a 51% reduction in risk of disease progression or death in comparison with crizotinib in patients with advanced ALK-positive non-small cell lung cancer who had not received ALK inhibitor. The approval has been based on the results from Phase 3 ALTA 1L trial. It evaluated the safety and efficacy of Alunbrig.
Alunbrig is a potent and selection next-generation TKI (Tyrosine Kinase Inhibitor) designed to target ALK molecular alterations. This approval expands Alunbrig’s current indication to include first-line setting. Teresa Bitetti, President, Global Oncology Business Unit, Takeda said, “We’re extremely proud of the positive results ALUNBRIG has shown for newly diagnosed ALK+ NSCLC patients, particularly those with brain metastases.” According to the team, this approval is a substantial progress in the right direction and represents significant progress for lung cancer portfolio of Takeda.
In this study, they evaluated that Alunbrig reduced the risk of disease progression or death twofold in comparison with crizotinib. It also demonstrated overall response rate of 74% for Alunbrig and 62% for crizotinib as assessed by a BIRC. Alunbrig also demonstrated a confirmed intracranial ORR for patients with measurable brain metastases at baseline of 78% for patients with Alunbrig and 26% for patients with crizotinib.
Alunbrig is currently approved in more than 40 countries for treatment of patients with ALK+ metastatic NSCLC who have taken the medicine crizotinib, but their NSCLC has worsened or cannot tolerate taking crizotinib. Also, Alunbrig is approved in the EU as a monotherapy for patients with ALK+ advanced NSCLC previously not treated with ALK inhibitor.
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