FDA Approves Alecensa (Alectinib) for Non-Small Cell Lung Cancer

The US Food and Drug Administration (FDA) has approved Alecensa (alectinib) to treat people with advanced ALK-positive non-small cell lung cancer (NSCLC) that has become worse after treatment with another targeted therapy drug called Xalkori (crizotinib). It’s also for people who could not tolerate taking Xalkori in the first place.

About 5% of NSCLCs have been found to have a rearrangement in a gene called ALK. This change is most often seen in non-smokers (or light smokers) who have the adenocarcinoma subtype of NSCLC. Doctors may test cancers for changes in the ALK gene to see if drugs that target this change may help them.

Alecensa is taken by mouth. It is thought to work by blocking the activity of the ALK protein, which may prevent NSCLC cells from growing and spreading. In metastatic cancer, the disease spreads to new parts of the body. In ALK-positive NSCLC patients, the brain is a common place for the disease to spread.

“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 Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, 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.”

The FDA based its approval on 2 clinical trials of people with metastatic ALK-positive NSCLC whose disease could not be controlled with Xalkori. Study participants received Alecensa twice a day. In the first study, 38% of participants saw a partial shrinkage of their lung tumors, an effect that lasted for an average of 7.5 months. In the second study, 44% of participants saw a partial shrinkage of their lung tumors, lasting for an average of 11.2 months. The trials also looked at Alecensa’s effect on tumors that had spread to the brain. Of the participants who had measureable brain metastases, 61% saw a complete or partial reduction in their brain tumors, lasting an average of 9.1 months.

The most common side effects of Alecensa are fatigue, constipation, swelling (edema) and muscle pain (myalgia). Alecensa may cause serious side effects, including liver problems, severe or life-threatening inflammation of the lungs, very slow heartbeats and severe muscle problems. Alecensa may make people burn more easily when out in the sun.

Alecensa was approved using several FDA approaches designed to speed up the availability of drugs to treat serious diseases – breakthrough therapy designation, priority review, and accelerated approval. It was also granted orphan drug designation, which provides financial incentives to encourage the development of drugs for rare diseases.

Alecensa is marketed by Genentech.

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