Ariad Pharmaceuticals has announced the initiation of a new drug application (NDA) submission for its investigational anaplastic lymphoma kinase (ALK) inhibitor brigatinib to the FDA. The company is seeking marketing approval of brigatinib for the treatment of patients with ALK-positive (ALK+) non–small-cell lung cancer (NSCLC) who are resistant to crizotinib (Xalkori, Pfizer).
Brigatinib received a 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 status for the treatment of ALK+ NSCLC.
Ariad’s NDA is a rolling submission that 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 the annual meeting of the American Society of Clinical Oncology earlier this month, showed that 54% of NSCLC patients receiving the 180-mg regimen achieved a confirmed objective response, the trial’s primary endpoint. In this arm, median progression-free survival was 12.9 months. In addition, a confirmed intracranial objective response rate of 67% (12/18) was achieved in patients with measurable brain metastases.
The most common treatment-emergent adverse events (TEAEs), regardless of relationship to treatment, included nausea, diarrhea, cough, and headache. TEAEs of grade 3 or greater included increased blood creatine phosphokinase and hypertension.
Brigatinib is an investigational, targeted cancer medication in development for the treatment of patients with ALK+ NSCLC whose disease is resistant to crizotinib. Brigatinib is currently being evaluated in the global phase 2 ALTA trial, which is the basis for its initial regulatory review. Ariad Pharmaceuticals has also initiated the phase 3 ALTA 1L trial to assess the efficacy of brigatinib in comparison with that of crizotinib.
Source: Ariad Pharmaceuticals; June 17, 2016.