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Ceritinib found safe and effective for NSCLC
Major finding: Oral ceritinib was found to be safe, with a maximum tolerated dose of 750 mg daily, and it elicited an overall tumor response rate...
Ceritinib, an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor, has been approved for the treatment of metastatic ALK-positive non–small cell lung cancer, in patients who have progressed on or are intolerant to crizotinib, the Food and Drug Administration announced on April 29.
The accelerated approval of ceritinib, marketed as Zykadia by Novartis, was based on the tumor response rate and duration of the response in an open label study of 163 people with metastatic ALK-positive non–small cell lung cancer (NSCLC), who had progressed during treatment with crizotinib or had not tolerated the drug; all were treated with ceritinib. Tumors shrunk in about half of the patients, an effect that lasted for a median of about 7 months, according to the FDA statement announcing the approval.
The most common side effects of the drug include diarrhea, nausea, vomiting, and abdominal pain; and elevated transaminases. The recommended dose is 750-mg dose once a day. It is available in 150-mg capsules.
Crizotinib, marketed as Xalkori, is the only other ALK tyrosine kinase inhibitor approved by the FDA; it was approved in 2011.
The FDA is approving ceritinib under the agency’s accelerated approval program, through which a drug can be approved to treat a serious or life-threatening disease based on clinical data showing effects on a surrogate endpoint that is "reasonably likely to predict clinical benefit." The manufacturer is required to conduct clinical trials to confirm the results.
The drug’s prescribing information includes the statement that "an improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials."
The FDA statement cited National Cancer Institute estimates that NSCLC accounts for about 85% of lung cancers, of which only 2%-7% are ALK positive. This year, about 224,210 people in the United States will be diagnosed with lung cancer and about 159,260 people will die from lung cancer, according to NCI.