FDA approves first new lung cancer drug in 6 years

On August 26, Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) had approved Xalkori (crizotinib) capsules. The drug is the first therapy targeting anaplastic lymphoma kinase (ALK), for the treatment of patients with locally advanced or metastatic nonsmall cell lung cancer (NSCLC) that is ALK-positive as detected by an FDA-approved test.

The effectiveness of Xalkori is based on objective response rates and, as Xalkori received accelerated approval from the FDA, Pfizer is conducting post-marketing clinical trials to further evaluate the drug's clinical benefit.

"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," Ian Read, president and chief executive officer of Pfizer, said in a news release.

Aligned with the FDA's latest guidance on targeted therapies and companion diagnostics, Pfizer worked closely with the FDA and partnered with Abbott Molecular's business in Pfizer's clinical studies to ensure the simultaneous review and approval of Xalkori along with a diagnostic test, Abbott Molecular's Vysis ALK Break Apart FISH Probe Kit, to identify the presence of the ALK fusion gene.

The simultaneous approval of Xalkori in parallel with Abbott Molecular's ALK FISH Test marks the first time a Pfizer oncology drug or any lung cancer medication was developed and approved in parallel with a diagnostic test.

Xalkori is available immediately through a number of specialty pharmacies. Patients prescribed Xalkori can call 877-744-5675 for assistance accessing the medication.

For more information about the FDA-approved ALK test, call 855-TEST-ALK (837-8255). (Pfizer plans to charge $115,200 per patient per year for the drug, according to International Business Times.)

"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," Dr. Paul Bunn, professor of medicine and the James Dudley chair in cancer research at the University of Colorado, said in a news release. "Xalkori represents a paradigm shift in NSCLC treatment, where we're moving away from a one-size-fits-all approach to biomarker-based treatment decisions."

In the clinical trials for Xalkori, the study design required patients' tumors to prospectively test positive for the ALK fusion gene biomarker, increasing the likelihood of response to the treatment.

This method, a first for a lung cancer therapy not yet on the market, allowed researchers to observe a strong efficacy signal in a selected patient population. Preliminary epidemiology suggests that approximately 3-5 percent of NSCLC tumors are ALK-positive, translating to approximately 6,500 to 11,000 NSCLC patients in the U.S. each year.

"Approval of Xalkori underscores the important role of molecular biomarkers in cancer treatment," Dr. Joan Schiller, president of National Lung Cancer Partnership and chief of Hematology/Oncology, University of Texas Southwestern Medical Center, noted in a press release.

"We strongly encourage lung cancer patients to talk to their oncologists about molecular tumor testing. By having a full understanding of the molecular biology of their tumor, patients and physicians can make well-informed treatment decisions."