FDA Approves Alunbrig as Frontline Treatment for ALK-Positive NSCLC

The Food and Drug Administration approved Alunbrig (brigatinib) for the first-line treatment of patients with ALK-positive metastatic non—small cell lung cancer (NSCLC), as detected by an FDA-approved test.

“As with many forms of lung cancer, ALK-positive NSCLC is a complex and aggressive cancer that presents various treatment challenges for patients who are newly diagnosed, including those whose disease has spread to their brain,” Andrea Stern Ferris, President and CEO of the LUNGevity Foundation, said in a press release. “Having this option for newly diagnosed patients is exciting news for the ALK+ NSCLC community and adds to the remarkable progress we have witnessed in lung cancer treatment over the past decade.”

The agency based its approval on results from the phase 3 ALTA 1L trial, designed to evaluate Alunbrig compared with Xalkori (crizotinib) in adult patients with ALK-positive locally advanced or metastatic NSCLC who have not received prior treatment with an ALK inhibitor.

In the trial, Alunbrig improved progression-free survival (the time from treatment to disease worsening; median, 24 months versus 11 months), compared with Zalkori. The agent had superior overall response rates (74% versus 62%, respectively), as well as a superior intracranial overall response rate for patients with measurable brain metastases at baseline (78% versus 26%).

“Results from the ALTA 1L trial add brigatinib to the very short list of first-line treatment options for ALK-positive lung cancer patients that have proven to be superior to crizotinib. 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,” Dr. Ross Camidge, Joyce Zeff Chair in Lung Cancer Research at the University of Colorado Cancer Center, said in the release. “These data have established brigatinib’s potential in the first-line setting, and I’m confident the FDA approval will open a new window of possibilities for physicians and their patients.”

Check back later on what you need to know about this approval.