The twice-daily capsules are meant for patients with non-small cell lung cancer who have a unique gene known as an abnormal anaplastic lymphoma kinase(ALK). An ALK gene causes cancer growth and development.
Lung Cancer Drug Blocks Proteins
The FDA also approved a diagnostic test by Abbott Laboratories that screens for the gene. About 187,000, or 85 percent of the 220,000 lung cancer cases diagnosed yearly, are non-small cell lung cancer. "For many patients, this drug has been a lifesaver," Massachusetts General's Shaw told ABC News. Dr. Roy S. Herbst, chief of medical oncology at Yale Cancer Center, said that crizotinib's FDA approval was a "pivotal milestone" in lung cancer treatment.
Xalkori is used to treat certain patients with late-stage -- advanced or metastatic -- lung cancer along with an abnormal anaplastic lymphoma kinase (ALK) gene, which causes cancer development and growth.
“Targeted therapies such as Xalkori are important options for treating patients with this disease and may ultimately result in fewer side effects.”
Patients with this form of lung cancer are typically non-smokers.
Xalkori is approved for the roughly four percent of patients with non-small cell lung cancer who have the gene.
Pfizer plans to charge $115,200 a year per patient for Xalkori.
“The approval of Xalkori with a specific test allows the selection of patients who are most likely to respond to the drug,” said Dr. Richard Padzur, MD, who heads the oncology drug unit of FDA's Center for Drug Evaluation and Research. In clinical trials, half or more patients benefited from the drug, and the one-year survival rate was 77%.
If testing were to become universal, that could mean around $30,000 spent on tests for every patient that gets the drug, Herper estimated.
Pfizer engaged Abbott on crizotinib in 2009 based on Abbott's expertise in molecular diagnostics and global reach.