FDA Extends Approval of NSCLC Cancer Drug

Ceritinib (Zykadia) was recently granted regular approval by the US Food and Drug Administration for the treatment of metastatic non-small cell lung cancer (NSCLC) in patients whose tumors are anaplastic lymphoma kinase (ALK)-positive. The drug was granted accelerated approval in 2014 after results from a clinical trial showed an overall response rate of 44% in patients with NSCLC and ALK-positive tumors.

The new approval was based on data from the ASCEND trial, a randomized, active-controlled trial that included 189 patients with NSCLC and ALK-positive tumors randomly assigned to receive ceritinib and 187 patients with NSCLC and ALK-positive tumors who received doublet chemotherapy. Patients taking ceritinib experienced longer progression-free survival, longer median response duration, and had a higher overall response rate compared with patients in the chemotherapy arm (16.6 vs 8.1 months, 23.9 vs 11.1 months, and 73% vs 27%, respectively).
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Patients with measureable central nervous system (CNS) lesions on baseline brain scans treated with ceritinib had an overall intracranial response rate of 57% and median CNS response duration of 16.6 months.

The recommended dose of ceritinib is 750 mg, taken orally at least 1 hour before or 2 hours after a meal.

Common adverse reactions associated with ceritinib include diarrhea, nausea, vomiting, fatigue, abdominal pain, decreased appetite, and cough. Adverse reactions resulted in 66% of patients receiving reduced doses of ceritinib and 77% patients experiencing dose interruption.

—Melissa Weiss

Reference:

FDA broadens ceritinib indication to previously untreated ALK-positive metastatic NSCLC [press release]. FDA. https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm560873.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Published May 26, 2017. Accessed May 30, 2017.