Zykadia (Certinib) from Novartis

Sat, 09/05/2015 - 12:03

Highlighted as one of the four new medications to treat lung cancer approved by the FDA since 2011, Zykadia is the result of an approach based on a thorough understanding of a disease and its causes. Zykadia was developed to treat non-small cell lung cancer (NSCLC) caused by a defect of the anaplastic lymphoma kinase positive (ALK+) gene . While NSCLC represents about 85% of lung cancers, only approximately 5% of patients’ tumors are ALK+, leaving these patients with few treatment options. Several of these patients can effectively use crizotinib (another AKL inhibitor), but there is a small subset that is unresponsive or intolerant to this medication.

Novartis Pharmaceuticals developed this drug specifically to inhibit the autophosphorilation of AKL and the proliferation of ALK mediated cells to limit tumor growth. Zykadia has shown an objective response rate of 56.4% on a phase I study and 37.1% in phase II study. While at this point there is insufficient clinical information to determine whether patients treated with Zykadia live longer, a median duration of response was estimated at eight and half months in the phase I study and nine months in the phase II study. Further studies are being implemented to measure the effects of Zykadia over longer periods of time. Zykadia was approved by the FDA in April 2014 and by the EMA in February 2015. It was approved for use in Mexico by COFEPRIS in March 2015.