FDA Approves Alectinib as First-Line Treatment of ALK-Positive Metastatic Lung Cancer
The U.S. Food and Drug Administration (FDA) granted regular approval of the supplemental New Drug Application for alectinib (Alecensa) for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non–small cell lung cancer (NSCLC), as detected by an FDA-approved test, according to an announcement by Genentech on November 6, 2017.
In 2015, alectinib received accelerated approval in the treatment of patients with metastatic ALK-positive NSCLC whose disease had progressed on or who could not tolerate treatment with crizotinib.
This current approval is based on data from the phase III randomized ALEX study. When compared with crizotinib, alectinib extended progression-free survival by 47%. The median progression-free survival for those who received alectinib was 25.7 months compared with 10.4 months for those who received crizotinib. In addition, the study revealed that alectinib reduced the risk of the cancer spreading to or growing in the brain or central nervous system by 84% when compared with crizotinib.
The most common adverse reactions (occurring in ≥ 20% of patients taking alectinib in the ALEX trial) were fatigue, constipation, edema, myalgia, and anemia. Serious adverse reactions occurred in 28% of patients treated with alectinib.