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4/30/2014

Ceritinib Approved for Advanced Lung Cancer

Kate Traynor

FDA External Link and NovartisExternal Link on April 29 announced the approval of the tyrosine kinase inhibitor ceritinib for the treatment of advanced lung cancer.

According to the labeling (PDF)External Link for ceritinib, the drug is indicated for the treatment of anaplastic lymphoma kinase-positive metastatic non-small-cell lung carcinoma (NSCLC) in patients whose illness has progressed during crizotinib therapy or who cannot tolerate that drug.

FDA approved ceritinib under the agency's breakthrough therapy program on the basis of data showing a favorable and durable tumor response to the drug. It is not yet known whether ceritinib therapy improves disease-related symptoms or extends the life of patients with NSCLC.

Novartis will market ceritinib as Zykadia. A Novartis representative stated that the product is expected to be available from specialty pharmacies within a few weeks.

The recommended dosage of ceritinib is five 150-mg oral capsules (750 mg total) taken once daily on an empty stomach. Because food greatly increases systemic exposure to the kinase inhibitor and could thus increase adverse reactions, ceritinib should never be taken within two hours of a meal.

A table in the labeling describes adverse events and laboratory test findings that necessitate a reduced dosage of ceritinib. Therapy should be permanently discontinued in patients who cannot tolerate the drug at 300 mg/day, the lowest recommended dosage.

Nearly all of the 255 patients enrolled in the pivotal clinical trial of ceritinib suffered diarrhea, nausea, vomiting, or abdominal pain while taking the drug. Severe gastrointestinal symptoms were reported by 14% of the clinical trial participants.

A total of 59% of the clinical trial participants required a dosage reduction or treatment interruption in response to adverse events. Abnormal liver-enzyme test results, diarrhea, and vomiting were the most frequently reported events leading to a dosage reduction or interruption of therapy.

The labeling for ceritinib includes warnings that the drug may cause gastrointestinal, liver, and fetal toxicity, interstitial lung disease, hyperglycemia and heart-rhythm abnormalities.

Ceritinib should not be used concurrently with strong inhibitors or inducers of cytochrome P-450 (CYP) isoenzyme 3A. If concurrent use is unavoidable, the labeling recommends a reduction in the ceritinib dosage.

Ceritinib should not be used concurrently with CYP 3A or 2C9 substrates that have a narrow therapeutic range. If concurrent use is necessary, a reduction in the dosage of the latter drugs should be considered.

Ceritinib will be available as 150-mg oral capsules in bottles of 70 each. The bottles should be stored at 25 °C.

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