NDA Submission Initiated for Brigatinib in ALK+ Non-small Cell Lung Cancer

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.

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.                                      

Reference

1. 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.