FDA Approves Alecensa for ALK-Positive NSCLC

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FDA Approves Alecensa for ALK-Positive NSCLC
FDA Approves Alecensa for ALK-Positive NSCLC

FRIDAY, Dec. 11, 2015 (HealthDay News) -- Alecensa (alectinib) has been approved by the U.S. Food and Drug administration to treat anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer, the agency said Friday in a news release.

Alecensa is designed to block the effects of the ALK protein, thereby preventing these cancer cells from growing and spreading. The pill is sanctioned for instances of worsening disease after treatment with Xalkori (crizotinib), or if they are unable to tolerate Xalkori.

The most common side effects of the drug are fatigue, constipation, edema, and myalgia. More serious side effects could include liver problems, life-threatening lung inflammation, very slow heart rate, and severe muscle problems. Users also may be prone to more easily becoming sunburned.

"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 Xalkori," Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in a statement. "In addition to the primary effect on tumors in the lung, Alecensa clinical trials provide evidence of an effect on tumors that had spread to the brain, which is an important effect for clinicians to understand."

Alecensa is marketed by San Francisco-based Genentech.

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