Alectinib Receives FDA Approval for First-Line Treatment of Stage 4 ALK-Positive Lung Cancer

On 6 November 2017, the United States Food and Drug Administration FDA approved treatment of stage 4 ALK-positive lung cancer with alectinib (trade name Alecensa) as first-line therapy.

Alectinib previously in December 2015, based on overall response rates of %38 and %44 in studies involving 87 and 138 patients, respectively, received accelerated approval from 2 single-arm studies for treating ALK-positive metastatic lung cancer in patients whose disease had progressed or who could not tolerate crizotinib, with FDA approval granted.

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This updated approval is based on the randomized, multicenter, open-label, active-controlled ALEX clinical trial involving 303 patients with ALK-positive lung cancer who had not received systemic treatment for metastatic disease. ALK positivity in all enrolled patients was confirmed by the Ventana ALK (D5F3) CDx Test. Patients were randomized into two groups: 152 received oral alectinib twice daily, and 151 received oral crizotinib at 250 mg twice daily.

The study found that median duration of disease control with treatment (progression-free survival) was 25.7 months in patients receiving alectinib and 10.4 months in the crizotinib arm.

Brain metastasis involvement was assessed in all patients. Among 43 patients with identified brain metastases, treatment response was %81 in the alectinib arm and %50 in the crizotinib arm. The most common side effects were fatigue, constipation, edema, muscle pain and anemia. Serious side effects occurred in %28 of patients treated with alectinib. In %11, alectinib was discontinued because of side effects. Side-effect-related dose interruptions occurred in %19, and dose reductions in %11. The recommended alectinib dose is 600 mg orally twice daily with food.

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