FDA approves Ceritinib (Zykadia) for non-small cell lung cancer

29 Apr 2014

The US FDA has granted accelerated approval for ceritinib (trade name: Zykadia) for treatment of a less common subtype of non-small cell lung cancer (NSCLC).

The approval covers patients with tumors that overexpress anaplastic lymphoma kinase (ALK) and have progressed during or after treatment with crizotinib (Xalkori). Although NSCLC accounts for about 85% of lung cancer, the ALK-positive subset makes up 2% to 7% of NSCLC.

"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 FDA's Office of Hematology and Oncology Products, said in a statement. "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 won the breakthrough-therapy designation after the FDA concluded that manufacturer Novartis had provided preliminary clinical evidence "that the drug may offer a substantial improvement over available therapies." The agency also granted priority review and orphan-drug designation to the agent.

Accelerated approval

Data submitted to the FDA also met criteria for accelerated approval, which takes into consideration a surrogate endpoint likely to predict a clinical benefit for patients. In the case of ceritinib, the surrogate endpoint was overall response rate. A single-arm clinical trial of 163 patients with ALK-positive NSCLC showed that about half the patients had tumor shrinkage that lasted for an average of 7 months with ceritinib treatment.

Side effects include diarrhea, nausea, vomiting & abdominal pain

According to the FDA statement, the most commonly reported side effects with ceritinib are diarrhea, nausea, vomiting, and abdominal pain. Laboratory abnormalities included elevated liver and pancreatic enzymes and hyperglycemia.



Source: MedPage Today: http://www.medpagetoday.com/HematologyOncology/LungCancer/45492

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