On August 26, 2011, the U.S. Food and Drug Administration (FDA) approved crizotinib (Xalkori) for the treatment of certain patients with late-stage, non–small cell lung cancers (NSCLC) who express the abnormal anaplastic lymphoma kinase (ALK) gene.
Between 1% and 7% of patients with NSCLC have the ALK gene abnormality, which causes cancer development and growth. This form of lung cancer is usually found in nonsmokers. Crizotinib works by blocking particular proteins, including the protein produced by the abnormal ALK gene.
“The approval of Xalkori with a specific test allows the selection of patients who are more likely to respond to the drug,” said Richard Pazdur, MD, director of the Office of Oncology Drug Products in the FDA Center for Drug Evaluation and Research. “Targeted therapies such as Xalkori are important options for treating patients with this disease and may ultimately result in fewer side effects.”
Two multicenter, single-arm studies involving a total of 255 patients with late-stage ALK-positive NSCLC established the safety and effectiveness of crizotinib. Prior to study enrollment, a sample of a patient’s lung cancer tissue was collected and tested for the ALK gene abnormality. Researchers measured the percentage of patients who experienced complete or partial cancer shrinkage. Most patients in the studies had received prior chemotherapy.
The objective response rate was 50%, with a median duration of response of 42 weeks, in one study. In another, the objective response rate was 61%, with a median duration of response of 48 weeks.
Crizotinib is approved with a first-of-a-kind genetic test called the Vysis ALK Break Apart FISH Probe Kit, a companion diagnostic test designed to determine if a patient has the abnormal ALK gene. Approval by the FDA of the Vysis ALK Break Apart FISH Probe Kit was based on data from one of the studies.
“The trend in oncology research continues towards targeted therapies,” said Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostic Device Evaluation and Safety in the FDA Center for Devices and Radiological Health. “This test is an example of the important role companion diagnostics play in determining that the safest and most effective treatments are promptly delivered to patients living with serious and life-threatening diseases.”
Source: FDA Press Release.
To sign up for our newsletter or print publications, please enter your contact information below.
