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

By Stacy Simon 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 ...
Source: American Cancer Society :: News and Features - Category: Cancer & Oncology Tags: Lung Cancer - Non-Small Cell Source Type: news