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Expanded Indication for Ceritinib to Previously Untreated ALK-Positive Lung Cancer

Posted: Tuesday, May 30, 2017

On May 26, 2017, the U.S. Food and Drug Administration (FDA) broadened the indication for ceritinib (Zykadia) to previously untreated patients with anaplastic lymphoma kinase (ALK)-positive metastatic non–small cell lung cancer (NSCLC). In April 2014, ceritinib received accelerated approval for patients with ALK-positive metastatic NSCLC whose disease has progressed or who are intolerant to crizotinib-based therapy.

The current approval is based on data from the randomized, multicenter, open-label, active-controlled ASCEND-4 trial. The 376 patients in this study had untreated ALK-positive NSCLC, with evidence of ALK rearrangement detected by an FDA-approved test. They received ceritinib orally once daily until disease progression or platinum-pemetrexed doublet chemotherapy.

An improvement in progression-free survival was seen in those who were treated with ceritinib vs chemotherapy (16.6 months vs 8.1 months). The confirmed overall response rate also favored ceritinib over chemotherapy (73% vs 27%). Overall survival data are immature.

In the ASCEND-4 trial, the most common adverse reactions (occurring in at least 25% of ceritinib-treated patients) were diarrhea, nausea, vomiting, fatigue, abdominal pain, decreased appetite, and cough. Serious adverse reactions occurred in 38% of patients treated with ceritinib. Adverse reactions leading to discontinuation of ceritinib occurred in 12%.