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.
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 performed through central laboratory testing,” the FDA said in a .
The recommended dose is 600 mg orally taken twice daily with food.