ARIAD Pharmaceuticals, Inc. announced the initiation of a New Drug Application (NDA) submission for its investigational anaplastic lymphoma kinase (ALK) inhibitor, brigatinib, to the U.S. Food and Drug Administration (FDA). ARIAD is seeking U.S. marketing approval of brigatinib for patients with ALK+ non-small cell lung cancer (NSCLC) who are resistant to crizotinib. 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.The Company is seeking accelerated approval for brigatinib from the FDA and plans to request a priority review of the application.
“We are ahead of our previously announced schedule for initiating the submission of our brigatinib NDA to the FDA and we are grateful to have breakthrough status from the FDA, which provides the opportunity to utilize the rolling submission process,” stated Paris Panayiotopoulos, president and chief executive officer of ARIAD. “If approved, we believe that brigatinib will become an important new medicine for ALK+ NSCLC patients who have become resistant or intolerant to prior crizotinib therapy and will offer additional hope to these patients and their families.”
ARIAD’s NDA is a rolling submission which will occur in three parts. The initial submission contains all nonclinical portions of the NDA and will be followed by submissions of the chemistry, manufacturing and controls (CMC) and clinical data. The rolling NDA submission is expected to be complete in the third quarter of 2016.
Results from the ongoing Phase 2 ALTA trial of brigatinib reported at this year’s annual meeting of the American Society of Clinical Oncology earlier this month showed that, in patients on the 180 mg regimen (Arm B, n=110) with a median follow-up of 8.3 months (range 0.1—20.2), 54 percent achieved a confirmed objective response, the trial’s primary endpoint. In this arm, the median progression free survival (PFS) exceeded one year (12.9 months) in this post-crizotinib setting. Additionally, a confirmed intracranial objective response rate (ORR) of 67 percent (12/18) was achieved in patients with measurable brain metastases.
Brigatinib is an investigational, targeted cancer medicine discovered internally at ARIAD. ARIAD has also initiated the Phase 3 ALTA 1L trial to assess the efficacy of brigatinib in comparison to crizotinib. More information on brigatinib clinical trials, including the expanded access program (EAP) can be found here.
