Novartis Pharmaceuticals Canada Inc. 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 or metastatic non-small cell lung cancer (NSCLC) who have
progressed on or who were intolerant to crizotinib.
"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 abnormalities. 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 tumor.
"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 months.
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