Xalkori Approved for Advanced Lung Cancer

powered by healthline

Average Ratings

Therapy targets abnormal gene

MONDAY, Aug. 29 (HealthDay News) -- Xalkori (crizotinib) and a companion diagnostic test have been approved by the U.S. Food and Drug Administration to treat advanced non-small cell lung cancer (NSCLC) with a certain genetic abnormality, the agency said in a news release.

The test and drug are aimed at NSCLC cancers that express an abnormal anaplastic lymphoma kinase (ALK) gene, which triggers cancer development and growth. About 1 percent to 7 percent of NSCLC cancers have the gene abnormality, the FDA said. Most people with this form of lung cancer are nonsmokers.

The drug's safety and effectiveness were established in a pair of clinical studies involving a total of 255 patients with late-stage ALK-positive NSCLC. Accelerated approval was granted under a program that allows the agency to approve a medication if it is "reasonably likely to predict a clinical benefit to patients," the FDA said.

The most common side effects of Xalkori included vision problems, nausea, diarrhea, vomiting, swelling and constipation. The drug also has been associated with potentially life-threatening inflammation of lung tissue (pneumonitis).

Xalkori is marketed by Pfizer, based in New York City.

More information

Visit the U.S. Food and Drug Administration to learn more about this approval.

-- Scott Roberts
Copyright © 2011 HealthDay. All rights reserved.
Article from
Top of page
General Drug Tools
General Drug Tools view all tools
Tools for
Healthy Living
Tools for Healthy Living view all tools
Search Tools
Search Tools view all tools
Insurance Plan Tools
Insurance Plan Tools view all tools

What is a reference number?

When you register on this site, you are assigned a reference number. This number contains your profile information and helps UnitedHealthcare identify you when you come back to the site.

If you searched for a plan on this site in a previous session, you might already have a reference number. This number will contain any information you saved about plans and prescription drugs. To use that reference number, click on the "Change or view saved information" link below.

You can retrieve information from previous visits to this site, such as saved drug lists and Plan Selector information.