Ariad NDA Filed for Brigatinib in Lung Cancer Patients

Ariad Pharmaceuticals has completed a rolling NDA submission for its investigational anaplastic lymphoma kinase (ALK) inhibitor, brigatinib, for its use treating patients with metastatic ALK-positive non-small cell lung cancer who are resistant or intolerant to crizotinib. The company is seeking accelerated approval and has requested a priority review.

The submission is based on data from Ariad’s Phase 1/2 and pivotal Phase 2 ALTA trials in which patients who had experienced disease progression on crizotinib therapy were randomized to one of two brigatinib regimens. “With a median follow-up of 8.3 months, the data show that, for patients treated with the 180 mg regimen with a seven day lead-in at 90 mg (Arm B), 54% achieved an investigator-assessed confirmed objective response, the trial’s primary endpoint,” the company says. In this arm, the median progression free survival (PFS) exceeded one year (12.9 months).