LUNGevity Foundation applauds FDA's recent approval of XALKORI lung cancer drug

LUNGevity Foundation applauds the US Food and Drug Administration's (FDA) recent approval of XALKORI® (crizotinib) to treat lung cancer. The drug, introduced by Pfizer, Inc. showed such promise in early trials that it was given "fast track" status by the FDA.

LUNGevity Foundation President Andrea Stern Ferris called the FDA's approval of XALKORI incredibly positive, saying: "The trial results are remarkable, strengthening the body of evidence that targeted therapies hold great promise in treating this deadly cancer. Lung cancer is the nation's number one cancer killer. The federal government and the private sector need to invest in accelerating all of the other promising research now underway that can change the way we diagnose and treat lung cancer and save lives."

XALKORI is a member of a new class of drugs that work by inhibiting the anaplastic lymphoma kinase (ALK) gene. Alterations of this gene are thought to drive tumor development in certain cancers. XALKORI is approved for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is ALK-positive as detected by an FDA-approved test.  About 10,000 of the 222,000 Americans diagnosed with non-small-cell lung cancer each year could be expected to have the genetic abnormality. William Pao, associate professor of medicine, Vanderbilt-Ingram Cancer Center, said: "The approval of crizotinib is an exciting development.  It further validates the idea that lung cancers are very different at the molecular level, even though they may look similar under the microscope, and should be treated accordingly.  It also shows how fast translational research is becoming medical practice. ALK fusions in lung cancer were only first reported in 2007, and by 2010, we already had reports on the activity of a specific ALK inhibitor in patients with ALK fusion-positive lung cancer.  Hopefully, this is just the beginning of many new benefits for lung cancer patients."

In December 2010, the FDA granted Pfizer's XALKORI NDA Fast Track status, a designation that speeds the review of drugs for serious or life-threatening diseases and for an unmet medical need. Drugs that may offer major advances in treatment or may provide a treatment where no adequate therapy exists usually are given the status. The FDA then granted XALKORI Priority Review status, which shortened the review time from 10 months to six months.

Dr. Charles Rudin, director, Lung Cancer Therapeutics Program at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins and a member of LUNGevity Foundation's scientific advisory board said: "Crizotinib is a prime example of successful deployment of a targeted inhibitor against a driver mutation in lung cancer.  Like the EGFR inhibitors in EGFR-mutant lung cancer, crizotinib is remarkably effective against ALK-translocated lung cancer." He also pointed out the urgency of additional research, saying, "As with the EGFR inhibitors, acquired resistance to this targeted inhibitor is already emerging as an important problem, and is a focus of ongoing research in the field."