FDA Accepts Application for Lung Cancer Drug Brigatinib

Approval decision set for April 2017

The FDA has accepted for review the new drug application (NDA) for brigatinib (Ariad Pharmaceuticals), an investigational oral anaplastic lymphoma kinase (ALK) inhibitor, for patients with metastatic ALK-positive non–small-cell lung cancer (NSCLC) who have progressed during treatment with crizotinib. The FDA granted Ariad’s request for a priority review and has set an action date of April 29, 2017.

The NDA submission included clinical data from phase 1/2 and pivotal phase 2 trials of brigatinib. The FDA’s priority review status accelerates the review time from 10 months to a goal of six months from the filing of the application. Brigatinib has also received breakthrough therapy status for the treatment of patients with ALK-positive NSCLC whose tumors are resistant to crizotinib, and was granted an orphan drug designation for the treatment of patients with ALK-positive, ROS1-positive, and EGFR-positive NSCLC. 

Ariad has initiated a phase 3 study (ALTA 1L) to assess the efficacy and safety of brigatinib in comparison with that of crizotinib in patients with locally advanced or metastatic ALK-positive NSCLC who have not received prior treatment with an ALK inhibitor.

NSCLC is the most common form of lung cancer, accounting for approximately 85% of the estimated 228,190 new cases of lung cancer diagnosed each year in the United States, according to the American Cancer Society. ALK was first identified as a chromosomal rearrangement in anaplastic large-cell lymphoma. Genetic studies indicate that chromosomal rearrangements in ALK are key drivers in a subset of NSCLC patients as well. Approximately 3% to 8% of patients with NSCLC have a rearrangement in the ALK gene.

Source: Ariad Pharmaceuticals; October 31, 2016.