The rolling submission of the New Drug Application to the U.S. Food and Drug Administration (FDA) for brigatinib, an investigational anaplastic lymphoma kinase (ALK) inhibitor, is complete, according to an ARIAD Pharmaceuticals press release.1
ARIAD is seeking accelerated approval of brigatinib for patients with ALK-positive metastatic non-small cell lung cancer (NSCLC), and has requested a priority review of the application. If granted, a decision by the FDA is expected within 8 months from submission.
The NDA submission is based on clinical data from the phase 1/2 and pivotal phase 2 ALTA trials of brigatinib. Preliminary results from the ALTA trial showed that 54% of brigatinib-treated patients who had experienced disease progression on crizotinib therapy achieved a confirmed objective response.
In addition, 67% of patients with measurable brain metastases achieved an intracranial objective response. Median progression-free survival was 12.9 months.
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The most common treatment-emergent adverse events included nausea, diarrhea, cough, increased blood creatine phosphokinase, headache, and fatigue.
- ARIAD completes rolling submission of New Drug Application for brigatinib to the U.S. Food and Drug Administration [press release]. ARIAD website. http://investor.ariad.com/phoenix.zhtml?c=118422&p=irol-newsArticle&ID=2198158. Updated August 30, 2016. Accessed August 31, 2016.