How Supplied:
Caps—70
Zykadia (Ceritinib) Treatment of Metastatic Non-Small Cell Lung Cancer (NSCLC), United States of America
Zykadia (Ceritinib / LDK378) is an inhibitor of anaplastic lymphoma kinase (ALK) indicated for treatment of non-small cell lung cancer (NSCLC).
The drug was discovered and developed by Novartis Pharmaceuticals and approved by the US Food and Drug Administration (FDA) for treating ALK-positive metastatic NSCLC patients following treatment with Crizotinib in April 2014.
The Committee for Medicinal Products for Human Use (CHMP) of EMA adopted positive opinion for granting conditional marketing authorisation for Zykadia for the treatment of adult patients with ALK positive advanced NSCLC in February 2015. In May 2015, the European Commission (EC) approved the drug for the same indication in the European Union (EU).
Non-small cell lung cancer drug
Non-small cell lung cancer (NSCLC) is the most common type of cancer that accounts for approximately 85% of all lung cancers and is the leading cause of cancer-related deaths worldwide. The disease occurs when abnormal cells rapidly multiply and don't stop reproducing.
Zykadia mechanism of action
Zykadia contains an ALK inhibitor that works against the ALK gene involved in development of cancers. The drug is available in 150mg gelatin capsules for oral administration.
Clinical trials on Zykadia
Phase II clinical trials on Zykadia were conducted between July 2005 and October 2007. The open label, non-randomised and parallel assignment enrolled 85 patients with NSCLC.
The primary outcome measure of the study was clinical efficacy based on the eva luation of objective tumour response rate (RR). The secondary outcome measures included assessment of the safety of RAD001 monotherapy, additional clinical efficacy of RAD001 and the steady state levels of RAD001 in blood, and to investigate potential molecular markers predictive of clinical effect.
Novartis initiated another Phase II clinical trial on Zykadia in April 2012. The open label, multi-centre, interventional and parallel assignment enrolled 83 patients.
The primary outcome measure of the study was frequency and characteristics of dose limiting toxicities (DLTs) in 28 days, whereas the secondary outcome measures included overall survival (OS), frequency, duration and severity of adverse events (AEs), progression-free survival (PFS) and plasma concentration of INC280.
FDA-approval for Zykadia was based on results obtained from a pivotal phase III clinical trial. It was a single-arm, open-label study that enrolled 163 subjects with metastatic ALK-positive NSCLC, who progressed while receiving or were intolerant to Crizotinib.
Patients were administered with Zykadia at a dose of 750mg once-daily. The study enrolled patients with a median age of 52 years. The most common sites of metastases eva luated in the clinical study included brain, liver and bone.
Results of the study demonstrated that the patients who were treated with Zykadia achieved an overall response rate (ORR) of 54.6% and a median duration of response (DOR) of 7.4 months.
The most common adverse reaction found in the Zykadia-administered patients during the clinical study included diarrhoea, nausea, elevated transaminases, vomiting, abdominal pain, fatigue, decreased appetite and constipation.
Safety and efficacy of Zykadia were eva luated in Study 1, w