FDA Approves Alectinib for Advanced ALK-Positive NSCLC
The U.S. Food and Drug Administration (FDA) today granted accelerated approval to alectinib (Alecensa) for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive non–small cell lung cancer (NSCLC) who have had disease progression on or are intolerant to crizotinib (Xalkori).
“Today’s approval provides a new therapy for a group of patients who would have few treatment options once their disease no longer responds to treatment with [crizotinib],” said Richard Pazdur, MD, Director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “In addition to the primary effect on tumors in the lung, [alectinib] clinical trials provide evidence of an effect on tumors that had spread to the brain, which is an important effect for clinicians to understand.”
Clinical Trial Results
The safety and efficacy of alectinib were studied in two single-arm clinical trials of patients with metastatic ALK-positive NSCLC whose disease was no longer controlled by treatment with crizotinib. Study participants received alectinib twice daily to measure the drug’s effect on their lung cancer tumors.
In the first study, 38% of participants experienced a partial shrinkage of their NSCLC tumors, an effect that lasted for an average of 7.5 months. In the second study, 44% of participants experienced a partial shrinkage of their NSCLC tumors, lasting for an average of 11.2 months.
The trials also examined alectinib’s effect on individuals’ brain metastases, a common occurrence in this population. Sixty-one percent of participants in the two trials who had measurable brain metastases experienced a complete or partial reduction in their brain tumors, lasting an average of 9.1 months.
The most common side effects of alectinib are fatigue, constipation, edema, and myalgia. Alectinib may cause serious side effects, including liver problems, severe or life-threatening inflammation of the lungs, very slow heartbeats, and severe muscle problems. Treatment with alectinib may cause sunburn when patients are exposed to sunlight.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
