FDA Approves Ceritinib for Metastatic Lung Cancer — Physician’s First Watch
FDA Approves Ceritinib for Metastatic Lung Cancer
By Kristin J. Kelley
The anaplastic lymphoma kinase (ALK) inhibitor ceritinib (marketed as Zykadia) has been granted accelerated approval to treat metastatic non–small-cell lung cancer (NSCLC) in patients with a mutation of the ALK gene who have been previously treated with crizotinib.
Only 2% to 7% of patients with NSCLC have ALK-positive tumors but, writes Anne Tsao in NEJM Journal Watch Oncology and Hematology, resistance to crizotinib is a significant problem in this population.
Approval was based on a trial in which some 160 patients with metastatic ALK-positive NSCLC were treated with ceritinib. Tumors shrunk in half of these patients — an effect that lasted, on average, about 7 months.
A Novartis official says that pricing information for the drug isn't available yet. However, PMLiVE reports that it will launch at $13,500/month.