On April 29, the Food and Drug Administration (FDA) granted accelerated approval to Zykadia (ceritinib) to treat patients with a subtype of advanced non-small cell lung cancer (NSCLC).
Zykadia inhibits the mutated protein anaplastic lymphoma kinase (ALK), which is caused by an abnormality in the ALK gene and can promote abnormal cell growth. This abnormality is present in 3-7 percent of patients with NSCLC. Zykadia is specifically approved to treat patients with this abnormality who no longer respond to Xalkori (crizotinib), which is also approved to treat ALK-positive NSCLC patients.
Xalkori was the first drug approved for ALK-positive lung tumors and has since become a standard of care for this patient population. However, once patients become resistant to the drug, there has been no other approved therapy to offer them until now.
Zykadia’s safety and effectiveness were established in a trial of 163 participants with Xalkori-resistant, ALK-positive NSCLC. All participants received Zykadia, and about half of the participants had their tumors shrink, a result that lasted for a median of approximately seven months.
This decision comes four months before the review deadline. The accelerated approval review process allows patients earlier access to promising drugs while the manufacturer conducts confirmation trials. Zykadia was also given a breakthrough therapy designation, which is also designated to speed promising therapies through the review process, and is the fourth drug to be approved with this designation. (You can read more about this new designation here.)
Common side effects are mostly gastrointestinal, including diarrhea, abdominal pain, nausea and vomiting. Increased liver and pancreatic enzymes and glucose levels might also occur.
For more information, visit Zykadia.com or call 888-669-6682.
And for more information on lung cancer and genetic abnormalities, read CURE’s Spring 2014 feature “Research Reveals New Frontiers in Lung Cancer.”