(Reuters) - U.S. health regulators have approved ceritinib (Zykadia, Novartis) for advanced non-small cell lung cancer patients with a specific genetic mutation.
"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," the Food and Drug Administration said.
"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," Richard Pazdur, director of cancer products in FDA's Center for Drug Evaluation and Research, said in a statement.
Zykadia had received the FDA's new breakthrough designation, intended to speed up the review of medicines seen as an advance over existing therapies or filling a serious unmet need. It was approved four months ahead of the expected FDA decision date.
Zykadia's safety and effectiveness were established in a clinical trial of 163 participants with metastatic ALK-positive NSCLC. Results showed that about half of the participants had their tumors shrink, and this effect lasted an average of about seven months.
Common side effects of Zykadia include gastrointestinal symptoms such as diarrhea, nausea, vomiting and abdominal pain. Laboratory abnormalities such as increased liver enzymes, pancreatic enzymes and increased glucose levels were also observed.