Ariad completes rolling NDA for brigatinib
Ariad Pharmaceuticals Inc. (NASDAQ:ARIA) completed submission of a rolling NDA to FDA for brigatinib ( AP26113) to treat anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) in patients whose tumors are resistant to Xalkori crizotinib. The company is seeking accelerated approval and requested Priority Review of the dual inhibitor of ALK and EGFR, which has breakthrough therapy designation.
The NDA is based on data from the open-label, international, pivotal Phase II ALTA trial. Brigatinib produced a 46-54% objective response rate (ORR) in the study, according to an abstract released in May ahead of the American Society of Clinical Oncology (ASCO) meeting. At the June meeting, Ariad said brigatinib led to a median progression-free survival (PFS) of 9.2-12.9 months and a one-year overall survival rate of 71-80% (see BioCentury Extra, May 18). ...