ARIAD Pharmaceuticals has announced a New Drug Application (NDA) submission for brigatinib, an investigational anaplastic lymphoma kinase (ALK) inhibitor, to the U.S. Food and Drug Administration (FDA).1
The company is seeking approval to market brigatinib for patients with ALK-positive non-small cell lung cancer (NSCLC) who are resistant to the ALK inhibitor crizotinib. The FDA previously granted brigatinib Breakthrough Therapy designation and orphan drug designation for the treatment of ALK-positive NSCLC.
The NDA submission is expected to be completed in the third quarter of 2016.
The submission is based on results from the ongoing phase 2 ALTA trial, which demonstrated a 54% confirmed objective response rate in 110 post-crizotinib patients treated with brigatinib 180 mg. Median progression-free survival was 12.9 months and the confirmed intracranial objective response rate was 67% among the 18 patients with measurable brain metastases.
The most common treatment-emergent adverse events were nausea, diarrhea, cough, and headache. The most frequently reported grade 3 or worse treatment-emergent adverse events included elevated creatine phosphokinase and hypertension.
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Findings were presented at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL. The phase 3 ALTA 1L trial has also been initiated to evaluate the efficacy of brigatinib, compared with that of crizotinib, in a head-to-head trial.
- ARIAD initiates submission of new drug application for brigatinib to the U.S. Food and Drug Administration ahead of plan [news release]. Cambridge, MA: ARIAD Pharmaceuticals, Inc; June 17, 2016. http://investor.ariad.com/phoenix.zhtml?c=118422&p=irol-newsArticle&ID=2178510. June 27, 2016.