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FDA Approves Oral Lung Cancer Therapy

Alectinib treats ALK-positive NSCLC


The FDA has approved alectinib (Alecensa, Genentech) to treat patients with advanced (metastatic) anaplastic lymphoma kinase (ALK)-positive non–small-cell lung cancer (NSCLC) whose disease has worsened after, or who could not tolerate, treatment with crizotinib (Xalkori, Pfizer).

Lung cancer is the leading cause of cancer death in the U.S., with an estimated 221,200 new diagnoses and 158,040 deaths in 2015, according to the National Cancer Institute. An ALK gene mutation can occur in several different types of cancer cells, including lung cancer cells. ALK gene mutations are present in approximately 5% of patients with NSCLC. In patients with metastatic ALK-positive NSCLC, the brain is a common site for spread of the disease.

Alectinib is an oral medication that blocks the activity of the ALK protein, which may prevent NSCLC cells from growing and spreading.

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. The 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 studies also examined the effect of alectinib 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 adverse effects of treatment with alectinib included fatigue, constipation, edema, and myalgia. Alectinib may cause serious adverse effects, including liver problems, severe or life-threatening inflammation of the lungs, bradycardia, and severe muscle problems. Treatment with alectinib may cause sunburn when patients are exposed to sunlight.

Alectinib was approved using the accelerated approval regulatory pathway, which allows the FDA to approve products for serious or life-threatening diseases based on evidence that the product has an effect on an outcome that is reasonably likely to predict clinical benefit. In the case of alectinib, the tumor response to treatment, along with the duration of response, provided this evidence.

Alectinib also received breakthrough therapy and orphan drug designations as well as priority review status.

Source: FDA; December 11, 2015.

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