The FDA has approved brigatinib for adults with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer, according to a release from the manufacturer.
The approval follows the phase III ALTA 1L trial, which compared brigatinib to crizotinib in patients with ALK+ locally advanced or metastatic NSCLC who had not been treated with an ALK inhibitor. Results of the trial showed brigatinib reduced the risk of disease progression or death twofold (PFS hazard ratio = 0.49), with a 24-month median progression-free survival. The drug also had a confirmed response rate of 74% (95% CI: 66-81) compared to 62% (95% CI: 53-70) compared to crizotinib.
The manufacturer’s release also noted a 78% intracranial ORR for patients with measurable brain metastases at baseline, compared to 26% for crizotinib.
“Results from the ALTA 1L trial add brigatinib to the very short list of first-line treatment options for ALK+ lung cancer patients that have proven to be superior to crizotinib,” said Ross Camidge, MD, PhD, from the University of Colorado Cancer Center, in the release. “Compared to crizotinib, brigatinib demonstrated superior efficacy, especially among those with brain metastases at baseline, and a low pill burden, at one pill a day, which is an important factor when we could be controlling disease for years.”
Warnings for brigatinib include interstitial lung disease, pneumonitis, hypertension, and bradycardia. During the ALTA 1L trial, serious adverse reactions were reported in 33% of patients receiving brigatinib. The most common serious adverse reactions were pneumonia (4.4%), ILD/pneumonitis (3.7%), and pyrexia (2.9%). Fatal adverse reactions were reported in 2.9% of patients, including 1.5% from pneumonia, and 0.7% from a cerebrovascular accident, or multiple organ dysfunction syndrome. The most common adverse reactions during the trial were diarrhea, rash, and cough.
Brigatinib is currently approved in more than 40 countries for the treatment of ALK+ metastatic NSCLC patients who have previously taken crizotinib but could not tolerate the drug or their condition worsened. It is also approved in the European Union as a monotherapy. The drug previously received breakthrough therapy and orphan drug designations from the FDA.