Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions
Alunbrig Approved for ALK+ Metastatic NSCLC
Takeda news release; 2017 Apr 28
The FDA granted accelerated approval to Alunbrig for the treatment of patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC).
Indications: Alunbrig is a kinase inhibitor indicated for the treatment of patients with ALK+ metastatic NSCLC who have progressed on or are intolerant to crizotinib.
Dosage and administration: Recommended dose: 90 mg orally once daily for the first 7 days; if tolerated, increase to 180 mg orally once daily.
Efficacy and safety: Safety and efficacy was determined in a phase 2 trial showing that of the patients who received the new medication, 53% achieved an overall response. Median duration of response was 13.8 months. 67% of patients with measurable brain metastases achieved a confirmed intracranial overall response.
Side effects/risks: The most common adverse reactions are nausea, diarrhea, fatigue, cough, and headache.
Takeda Announces FDA Accelerated Approval of ALUNBRIGTM (brigatinib). [news release]. Cambridge, MA: Takeda Pharmaceutical Company Limited April 28, 2017. https://www.takeda.com/newsroom/newsreleases/2017/alunbrig-fda-approval/. Accessed April 30, 2017.
Alunbrig [package insert]. Cambridge, MA: Takeda Pharmaceutical Company Limited. 2017. https://www.alunbrig.com. Accessed April 30, 2017.