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FDA approves alectinib as frontline therapy for ALK-positive metastatic NSCLC


 

 

The Food and Drug Administration has approved frontline alectinib for the treatment of anaplastic lymphoma kinase (ALK)–positive metastatic non–small cell lung cancer (NSCLC) that has been detected by an FDA-approved test.

The drug previously received accelerated approval for treatment of patients with ALK-positive metastatic NSCLC whose disease progressed while receiving crizotinib or who were intolerant of that treatment.

FDA icon Wikimedia Commons/FitzColinGerald/Creative Commons License
Current approval of alectinib (Alecensa) as a frontline treatment was based on improvement in progression-free survival (hazard ratio, 0.53; P less than .0001) in a randomized, open-label trial of 303 patients with ALK-positive metastatic NSCLC who received either alectinib or crizotinib. The median progression-free survival time was 25.7 months in the alectinib group and 10.4 months in the crizotinib group.

There was also a lower incidence of progression to the central nervous system as first site of disease progression with alectinib: Incidence of progression to the CNS was 12% for patients receiving alectinib and 45% for patients receiving crizotinib.

The most common adverse events in patients receiving alectinib were fatigue, constipation, edema, myalgia, and anemia. Serious adverse events occurred in 28% of patients. Adverse events resulting in discontinuation occurred in 11% of patients.

“All patients in the trial were required to have evidence of ALK-rearrangement identified by the VENTANA ALK (D5F3) CDx Assay performed through central laboratory testing,” the FDA said in a press statement.

The recommended dose is 600 mg orally taken twice daily with food.
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