The US Food and Drug Administration today has granted accelerated approval to Zykadia (ceritinib) by Novartis for patients with a certain type of late-stage non-small cell lung cancer (NSCLC).
Zykadia is an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor that blocks proteins that promote the development of cancerous cells. It is intended for patients with metastatic ALK-positive NSCLC who were previously treated with crizotinib, the only other approved ALK tyrosine kinase inhibitor.
Lung cancer is the number one cause of cancer-related death in the United States. According to the National Cancer Institute, about 224,210 Americans will be diagnosed with lung cancer, and 159,260 will die from the disease this year.
NSCLC represents about 85 percent of lung cancers. Of those, only between 2-7 percent are ALK-positive.
"Today’s approval illustrates how a greater understanding of the underlying molecular pathways of a disease can lead to the development of specific therapies aimed at these pathways," said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. "It also demonstrates the FDA’s commitment to working cooperatively with companies to expedite a drug’s development, review and approval, reflecting the promise of the breakthrough therapy designation program."
Zykadia is the fourth drug with breakthrough therapy designation to receive FDA approval. It is being approved four months ahead of the product’s prescription drug user fee goal date of Aug. 24, 2014, the date the agency was scheduled to complete review of the drug application.
The FDA granted Zykadia breakthrough therapy designation, priority review and orphan product designation, is currently being approved under the agency’s accelerated approval program.
Zykadia’s safety and effectiveness were established in a clinical trial of 163 participants with metastatic ALK-positive NSCLC. All participants were treated with Zykadia. Results showed that about half of the participants had their tumors shrink, and this effect lasted an average of about seven months.
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