FDA approves first and only therapeutic drug for ALK-positive lung cancer

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"I know the names and I can see the faces of every ALK-positive patient I have treated with crizotinib. Most of them would not be alive today if not for this drug," says Ross Camidge, investigator at the University of Colorado Cancer Centre and oncologist at the University of Colorado School of Medicine, who has been involved with the drug since its first trials in 2008.

Approximately 4% of the 220 000 Americans diagnosed with lung cancer each year have the ALK fusion gene, and 45 000 newly diagnosed lung cancer patients are ALK positive worldwide. The drug crizotinib targets this ALK fusion gene - which is expressed only in cancer cells and not their healthy neighbours - starving cancer cells of the energy they need to live and grow.

"By truly understanding the underlying genetic drivers of lung cancer, such as ALK, we can select patients who are more likely to respond to treatment. Crizotinib provides a model for how to approach future drug development and cancer care," says Paul Bunn, investigator at the University of Colorado Cancer Centre and professor of medicine and the James Dudley chair in cancer research at the University of Colorado School of Medicine. "Crizotinib, the first new drug approved for lung cancer by the FDA in more than six years, represents a paradigm shift in lung cancer treatment, where we're moving away from a one-size-fits-all approach to biomarker-based treatment decisions."

A major achievement

The approval of this drug is also a major achievement for the University of Colorado Cancer Centre, which has been involved in all phases of the drug's development and use, including creating the clinical test for ALK-positive lung cancers and enrolling the first patients in the phase I study of the drug, in 2008.

The approval of crizotinib marks the start of FDA-approved, personalised treatment for lung cancer.

Headquartered on the University of Colorado Anschutz Medical Campus, the CU Cancer Centre is a consortium of three state universities and six institutions. Together, our more than 435 members are committed to transforming cancer research in the state of Colorado by creating an interdisciplinary nexus of clinicians and scientists who will discover, develop and deliver breakthroughs to prevent and treat cancer in Colorado and around the world. Learn more at coloradocancercentre.org.

Source: Colorado State university