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.