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Breakthrough therapy for late-stage lung cancer gets FDA approval

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The FDA has accelerated approval to Zykadia (ceritinib) for patients with a certain type of late-stage (metastatic) non-small cell lung cancer following a clinical trial involving 163 participants with the disease. Results showed that about half of the participants had their tumors shrink, with effects from the drug lasting an average of 7 months.

Common side effects of the drug include diarrhea, nausea, vomiting and abdominal pain. In addition, increased liver enzymes, pancreatic enzymes and increased glucose levels were also observed.

“This 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.”

According to the National Cancer Institute, lung cancer remains the leading cause of cancer-related deaths in the US, with approximately 224,210 new cases expected to be diagnosed this year, resulting in “159,260 deaths.” They also stated that nearly 85% of lung cases being non-small cell lung cancer, making NSCLC “the most common form of the disease.” However, only 2-7% of patients with NSCLC are ALK-positive.



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