US FDA approves Pfizer lung cancer drug Xalkori and companion diagnostic from Abbott

The US Food and Drug Administration has approved global drugs behemoth Pfizer’s (NYSE: PFE) Xalkori (crizotinib) to treat certain patients with late-stage (locally advanced or metastatic), non-small cell lung cancers (NSCLC) who express the abnormal anaplastic lymphoma kinase (ALK) gene.

Xalkori is being approved with a companion diagnostic test from Abbott Laboratories (NYSE: ABT) that will help determine if a patient has the abnormal ALK gene, a first-of-a-kind genetic test called the Vysis ALK Break Apart FISH Probe Kit, which was also approved by the agency on Friday. It is the second such targeted therapy approved by the FDA this year.

Xalkori was cleared several weeks ahead of schedule under the FDA’s accelerated approval program, which allows the agency to approve a drug to treat a serious disease based on clinical data showing that the drug has an effect on an endpoint that is reasonably likely to predict a clinical benefit to patients. However, so-called personalized medicines come at a somewhat hefty cost; Pfizer says the treatment will cost $9,600 a month, or $115,000 for patients who take it for a year.