Alecensa (alectinib), an oral medication for the treatment of advanced ALK-positive non-small cell lung cancer (NSCLC), has been approved and granted breakthrough therapy -- in addition to orphan drug designation -- by the U.S. Food and Drug Administration (FDA).
Alecensa is for patients who have been unsuccessfully treated with Xalkori (crizotinib), one of the most commonly used NSCLC therapies.
“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,” Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said. “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 works by blocking the activity of the ALK protein. It has been the subject of two clinical trials. In the first, the tumors of 38 percent of patients treated with Alecensa shrank and experienced no growth for an average of 7.5 months; in the second, tumors shrank in 44 percent of patients, and no tumor growth occurred for an average of 11.2 months.
Additionally, over half the patients in both studies experienced partial shrinkage of brain tumors related to their lung cancers.
Alecensa is marketed by San Francisco, California-based pharmaceutical company Genentech.
