Alectinib Approved in US for Refractory ALK-Positive NSCLC

Zosia Chustecka


December 11, 2015

Another targeted agent for non-small-cell lung cancer (NSCLC) that is positive for the ALK rearrangement (found in about 5% of NSCLC patients) has just been approved by the US Food and Drug Administration (FDA). The new drug, alectinib (Alecensa, Genentech), is also active on brain metastases.

Alectinib is indicated for use in patients with advanced ALK-positive NSCLC that is no longer responding to crizotinib (Xalkori, Pfizer), the first ALK-specific agent that was approved in 2001. This is a similar indication to that approved last year for ceritinib (Zykadia, Novartis), which is also indicated for ALK-positive NSCLC no longer responding to crizotinib. But for the new drug, the agency highlighted its additional effects.

"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," noted Richard Pazdur, MD, director of the Office of Hematology and Oncology Products at the FDA Center for Drug Evaluation and Research. 

Data From Single-Group Studies

The data supporting the approval of alectinib come from two single-group studies, in which it was given to patients with metastatic ALK-positive NSCLC whose disease was no longer controlled by treatment with crizotinib.

In the first study, 38% of patients 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 patients experienced a partial shrinkage of their NSCLC tumors, lasting for an average of 11.2 months.

The trials also examined the effect of alectinib on brain metastases, a common occurrence in this population, the FDA noted. In both trials together, 61% of patients 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 adverse effects of alectinib are fatigue, constipation, edema, and myalgia, the agency notes. The drug may also cause severe liver problems, severe or life-threatening inflammation of the lungs, very slow heartbeats, and severe muscle problems. In addition, the drug can cause photosensitivity leading to sunburn when patients are exposed to sunlight.

Alectinib was approved using the accelerated approval regulatory pathway, and the product was granted breakthrough therapy designation and priority review status, as well as orphan drug designation.


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