The Food and Drug Administration announced that it has approved Pfizer’s new drug for treating non-small-cell lung cancer patients with a specific genetic mutation.
Nearly 1 to 7% NSCLC patients have an abnormal gene that causes tumor growth. The proteins produced by the abnormal gene are inhibited by Pfizer’s drug Xalkori.
President and chief executive officer of Pfizer, Ian Read, said: “Overall, lung cancer is responsible for more deaths each year worldwide than any other type of cancer. XALKORI is an advance in the treatment of this devastating illness, providing a new therapeutic option for a subset of patients with the disease. The acceleration, collaboration, and critical focus of the XALKORI clinical development program reflect Pfizer’s Precision Medicine approach to advancing our pipeline and strengthening our innovative core to deliver medicines that matter most.”
The FDA has approved the second the twice-a-day pill that targets a specific genetic mutation. These drugs form a part of personalized medicines developed to cancer and other life-threatening diseases.
Director of the Office of Oncology Drug Products, Center for Drug Evaluation and Research, FDA, Richard Pazdur, M.D., said: “The approval of Xalkori with a specific test allows the selection of patients who are more likely to respond to the drug. Targeted therapies such as Xalkori are important options for treating patients with this disease and may ultimately result in fewer side effects.”
According to the FDA, a genetic test designed to screen patients with an abnormal anaplastic lymphoma kinase gene has also been approved by the agency. Non-small-cell lung cancers account for nearly 85% of all lung cancer cases.
Director of the Office of In Vitro Diagnostic Device Evaluation and Safety in the FDA’s Center for Devices and Radiological Health., Alberto Gutierrez, Ph.D., said: “The trend in oncology research continues towards targeted therapies. 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.”
Reported side effects with Xalkori include constipation, edema, vomiting, diarrhea, nausea, and vision disorders. Vision disorders may include double vision, photophobia, visual field defects, floaters, and blurred vision.
Professor of medicine and the James Dudley chair in cancer research at the University of Colorado, Denver, Dr. Paul Bunn, said: “By truly understanding the underlying genetic drivers of NSCLC, such as ALK, we can select patients who are more likely to respond to treatment. Xalkori provides a model for how to approach future drug development and cancer care. Xalkori, the first new drug approved for lung cancer by the FDA in more than six years, represents a paradigm shift in NSCLC treatment, where we’re moving away from a one-size-fits-all approach to biomarker-based treatment decisions.”
The manufacturer and marketer of Xalkori, Pfizer Inc., said that the drug is immediately available at some specialized pharmacies.