UK NICE issues positive recommendation for Zykadia (ceritinib) to treat ALK+ non small cell lung cancer- Novartis

UK's NICE has announced that Zykadia (ceritinib), from Novartis, has been recommended in line with its marketing authorisation, for the treatment of advanced ALK-positive non small cell lung cancer (NSCLC) in adults who have previously been treated with Pfizer's Xalkori (crizotinib). The regulator's decision is dependent on the continued provision of a patient access scheme, in which Novartis contnues to offer the drug to the NHS at a discounted price to ensure value for money. This is in contrast to the decision announced by NICE in November 2015.

Comment: Ceritinib is structurally distinct from crizotinib and has a 20-fold greater potency against the target than its more advanced 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. Approximately 2-7% of patients with NSCLC harbour the ALK gene rearrangement, which causes cancer growth.