Brigatinib NDA Accepted for FDA Review
ARIAD announced that the Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for brigatinib to treat patients with metastatic ALK+ non-small cell lung cancer (NSCLC) who have progressed on crizotinib.
Brigatinib is an investigational oral anaplastic lymphoma kinase (ALK) inhibitor. The NDA submission was supported by data from its Phase 1/2 and Phase 2 ALTA (ALK in Lung Cancer Trial of AP26113) trials. The Phase 2 trial was designed to determine the safety and efficacy of brigatinib in the treatment of refractory ALK+ NSCLC (n=220), including those with brain metastases. Patients were randomized to either brigatinib 90mg once daily or a lead-in dose of 90mg daily for 7 days followed by 180mg once daily.
The Company has also begun a Phase 3 ALTA 1L trial to study the safety and efficacy of brigatinib vs. crizotinib in patients with locally advanced or metastatic ALK+ NSCLC who have not received prior treatment with an ALK inhibitor. In addition, an Expanded Access Study was initiated in June 2016 to provide brigatinib for patients on an expanded access basis due to their inability to meet eligibility criteria for recruiting trials, inability to participate in other trials, or due to medical interventions not considered acceptable or appropriate.
The FDA has granted the NDA Priority Review and has set a Prescription Drug User Fee Act (PDUFA) date of April 29, 2017. Brigatinib has previously received Breakthrough Therapy designation from the FDA as well as orphan drug designation.
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