The FDA has granted accelerated approval to Zykadia (ceritinib; Novartis) in patients with metastatic anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.
Zykadia is an ALK tyrosine kinase inhibitor that blocks proteins that promote tumor development. Ceritinib actively inhibits autophosphorylation of ALK, ALK-mediated phosphorylation of the downstream signaling protein STAT3, and proliferation of ALK-dependent cancer cells in in vitro and in vivo assays. Zykadia is the second approved ALK tyrosine kinase inhibitor after crizotinib.
Zykadia was granted breakthrough therapy designation, priority review, and orphan product designation following substantial preliminary clinical data. Its safety and effectiveness were established in a clinical trial of 163 patients with metastatic ALK-positive NSCLC. All participants were treated with Zykadia and about half of the patients had their tumors shrink for an average of 7 months.
Zykadia will be available in 150mg hard gel capsules in 70-count bottles.
For more information call (888) 669-6682 or visit Novartis.com.