ARIAD Completes Rolling Submission Of NDA To FDA For ALK Inhibitor Brigatinib

(RTTNews) - ARIAD Pharmaceuticals, Inc. (ARIA), a developer of precision therapies for patients with rare cancers, Tuesday said it has completed the rolling submission of the New Drug Application or NDA for its investigational anaplastic lymphoma kinase or ALK inhibitor, brigatinib, to the U.S. Food and Drug Administration.

ARIAD is seeking U.S. marketing approval of brigatinib for patients with metastatic ALK-positive non-small cell lung cancer who are resistant or intolerant to crizotinib.

Brigatinib is an investigational, targeted cancer medicine discovered internally at ARIAD. It is in development for the treatment of patients with anaplastic lymphoma kinase positive (ALK+) non-small cell cancer.

ARIAD's NDA submission includes clinical data from its Phase 1/2 and pivotal Phase 2 ALTA trials of brigatinib.

The company said it is seeking accelerated approval for brigatinib from the FDA and has requested a priority review of the application. If granted, it would allow for approval of brigatinib eight months after the NDA submission, as opposed to 12 months for a standard review.

Brigatinib received Breakthrough Therapy designation from the FDA for the treatment of patients with ALK+ NSCLC whose tumors are resistant to crizotinib, and was granted orphan drug designation by the FDA for the treatment of ALK+ NSCLC. ARIAD plans to submit a Marketing Authorization Application or MAA for brigatinib to the European Medicines Agency in early 2017.