Abbott Molecular, Pfizer get nod for drug, companion Dx

A partnership between two industry bigwigs has yielded fruit in the field of personalized medicine. The FDA has approved Pfizer's ($PFE) Xalkori (crizotinib) with a companion diagnostic test to treat certain patients with late-stage, non-small cell lung cancers (NSCLC) who express the abnormal anaplastic lymphoma kinase (ALK) gene. The test--the Vysis ALK break apart fluorescence in situ hybridization (FISH) probe kit--is marketed by Abbott Labs' ($ABT) molecular unit, which views the simultaneous approvals as a potential game changer for the diagnosis and treatment of patients with NSCLC. It's designed to identify the roughly 3% to 5% of NSCLC patients who would be candidates for the new drug.

Xalkori and its companion diagnostic were approved ahead of the diagnostics' Sept. 28 and the drug's Sept. 30 FDA review goal dates. It is the second such targeted therapy approved by the agency this year, the FDA says in a statement.

"The trend in oncology research continues towards targeted therapies," explains Alberto Gutierrez, director of the Office of In Vitro Diagnostic Device Evaluation and Safety in the FDA's Center for Devices and Radiological Health, in a statement. "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."

Lung malignancies are the leading cause of cancer deaths, with more than 1.6 million new cases diagnosed annually. About 85% of lung cancer patients have the NSC type and are usually diagnosed with advanced disease having a very low survival rate, according to an Abbott Molecular statement.

- see Abbott's release
- get the FDA's release