CHMP recommends Zycadia (ceritinib)to treat ALK + NSCLC- Novartis
Novartis announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion for Zykadia (ceritinib) to treat adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with Xalkori (crizotinib) from Pfizer. If approved in the European Union (EU), ceritinib will be the first treatment option to address an unmet medical need for patients with ALK+ NSCLC previously treated with crizotinib.
The most common type of lung cancer is NSCLC, accounting for 85-90% of all cases. Of those, 2-7% are driven by a rearrangement of the ALK gene, which increases the growth of cancer cells and can be identified by a molecular test of the cancer tumor. Despite significant treatment advances for patients with ALK+ NSCLC, disease progression is often inevitable and more treatment options are needed.
Comment: Ceritinib is structurally distinct from crizotinib and has a 20-fold greater potency against the target than its rival, making it a prime candidate for use in resistant patients. Despite high initial responses to Xalkori therapy, patients usually acquire resistance to the drug and relapse within a year. Resistance mechanisms involved include ALK gene mutation, ALK gene amplification or activation of other tyrosine kinases such as EFGR.
Patients with ALK+ NSCLC are often younger than the average NSCLC patient and in many cases have never smoked.