FDA approves Alecensa oral therapy

SILVER SPRING, Md. — The Food and Drug Administration on Friday announced the approval of Genentech’s new oral therapy Alecensa (alectinib). The drug is indicated to treat metastasized ALK-positive non-small cell lung cancer in patients who could not tolerate Xalkori (criznotinib) or whose illness worsened after that treatment. 

 

The drug blocks ALK protein activity in an effort to prevent the spread of cancer cells. About 5% of patients with NSCLC develop ALK gene mutations, which make it possible for the cancer to spread to a patient’s brain. 

 

“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,” said Dr. Richard Pazdur 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, 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.”