The U.S. Food and Drug Administration (FDA) has granted Priority Review for alectinib, an oral anaplastic lymphoma kinase (ALK) inhibitor, for the treatment of people with ALK-positive, non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to Xalkori™ (crizotinib). Alectinib was previously granted Breakthrough Therapy Designation by the FDA for people with ALK-positive NSCLC whose disease progressed on crizotinib.
A Priority Review designation is granted to medicines that the FDA has determined to have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease. Breakthrough Therapy Designation is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases and to help ensure people have access to them through FDA approval as soon as possible.
Lung cancer remains the leading cause of cancer-related deaths worldwide. In the United States, NSCLC accounts for 75–80% of all lung cancers. Although progress has been made in recent years, the majority of patients with advanced stage lung cancer still die from their disease. New treatments are sorely needed.
The priority review was based on the results from two studies previously presented at the Annual Meeting of the American Society of Clinical Oncology (ASCO).
Both studies evaluated alectinib in people with ALK-positive NSCLC whose disease progressed on Xalkori™. In the first study, alectinib shrank tumors in 47.8 percent of patients and activity was also observed in the central nervous system (CNS), a common and difficult to treat site of metastases from NSCLC.
In the second study an overall response rate of 50% was reported and alectinib again shrank tumors in the CNS. Alectinib was well tolerated without significant side effect in either study.
ALEX is an ongoing, global randomized Phase III study comparing alectinib to Xalkori™ as an initial (first-line) treatment for people with advanced NSCLC whose tumors were characterized as ALK-positive by a companion immunohistochemistry (IHC) test.
Source: Genetech PR
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