Novartis Receive Marketing Authorization For Zykadia From Health Canada
New therapeutic option now available for select treatment resistant lung cancer patients.
Novartis Pharmaceuticals Canada Inc. — a unit of Novartis — is pleased to announce that Health Canada has issued a marketing authorization with conditions for Zykadia (ceritinib), a lung cancer treatment that addresses an unmet medical need for patients with anaplastic lymphoma kinase (ALK)-positive locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) who have progressed on or who were intolerant to crizotinib7.
“The majority of ALK+ patients are younger and have never smoked, which represents a demographic that many are surprised to hear associated with this devastating illness. Until recently, treatment options have been limited.” states Dr. Jeffrey Rothenstein, MD, FRCPC. “Zykadia represents an important new option for patients who relapse after starting initial therapy.”
NSCLC can be characterized based on a patient’s genetic abnormalities that are causing the cancer growth and researchers have identified over 12 of these genetic abnormalities8. Of those, 2 to 7 per cent 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 tumor9.
“Developments in targeted gene therapy such as treatments targeting ALK rearrangements are helping us move towards personalized medicine,” states Shem Singh, Executive Director, Lung Cancer Canada. “Molecular testing should be done on a patient’s tumour as soon as there is a NSCLC lung cancer diagnosis. This will help patients and physicians identify the best treatment as quickly as possible.”
The marketing authorization with conditions for Zykadia™ was based on a pivotal Phase 1 trial that included 163 patients with metastatic ALK+ NSCLC who had received prior treatment with crizotinib. Among these patients, Zykadia™ achieved an overall response rate of 54.6% and the median duration of response was 7.4 months10.
“Novartis is committed to ongoing research in the area of lung cancer with the goal of developing new medicines to help improve the lives of cancer patients and their families. We are proud to be at the forefront of innovative research into personalized treatments that may help bring new solutions to more patients,” said Fionnuala Doyle, General Manager, Oncology, Novartis Pharmaceuticals Canada Inc.