First Approval for New ALK Inhibitor
The FDA approved ensartinib for certain patients with locally advanced or metastatic non-small cell lung cancer.
The U.S. Food and Drug Administration (FDA) has approved ensartinib (Ensacove) for adults with non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive, locally advanced or metastatic, and has not been previously treated with an ALK inhibitor.
This is the first FDA approval for ensartinib, a small molecule tyrosine kinase inhibitor that blocks the activity of the ALK protein, which promotes tumor growth when mutated. This second-generation ALK inhibitor is designed to address challenges associated with the first-generation ALK inhibitor crizotinib (Xalkori), such as high rates of resistance and an inability to effectively penetrate the blood-brain barrier.
This approval was based on results from eXALT3, an open-label, randomized, active-controlled, multicenter phase III study in which 290 patients with ALK-positive, ALK inhibitor-naive NSCLC were randomly assigned (1:1) to receive either ensartinib or crizotinib.
Patients treated with ensartinib had a 44% lower risk of disease progression than those treated with crizotinib. Half of the ensartinib-treated patients experienced at least 25.8 months of progression-free survival, compared to 12.7 months for crizotinib-treated patients.
The recommended dose of ensartinib is 225 mg orally once daily, until disease progression or unacceptable toxicity.
NSCLC is the most common type of lung cancer, with an estimated 3% to 11% of NSCLC cases characterized by aberrant ALK activity. According to federal statistics, it was estimated that 234,580 individuals would be diagnosed with lung cancer and 125,070 would die of the disease in the United States in 2024.
The FDA rendered its decision on December 18, 2024. Check this resource for updated information on all therapeutics regulated by the FDA.
