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FDA approves Zykadia for metastatic NSCLC
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The FDA today announced the accelerated approval of ceritinib — an anaplastic lymphoma kinase tyrosine kinase inhibitor — for patients with metastatic, ALK-positive non–small cell lung cancer.
Ceritinib (Novartis) is intended for patients who have previously been treated with crizotinib (Xalkori, Pfizer), the only other FDA-approved ALK TKI.
The approval is based on part on study results evaluating the agent in 163 patients, about half of whom experienced tumor shrinkage for a median of 7 months.
Gastrointestinal symptoms such as diarrhea, nausea, vomiting and abdominal pain were the most commonly observed adverse events among study participants. Researchers also observed increased liver and pancreatic enzymes, as well as increased glucose levels.
Richard Pazdur
“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, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “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.”
Ceritinib is the fourth drug to receive FDA approval with a breakthrough therapy designation, according to a press release from the FDA.