APR 08, 2015 04:00 PM PDT

New Therapeutic Option Available for Select Treatment Resistant Lung Cancer Patients

Novartis announces 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 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 percent 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 tumor 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 percent and the median duration of response was 7.4 months.

"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.

Source: Novartis Canada
About the Author
  • Ilene Schneider is the owner of Schneider the Writer, a firm that provides communications for health care, high technology and service enterprises. Her specialties include public relations, media relations, advertising, journalistic writing, editing, grant writing and corporate creativity consulting services. Prior to starting her own business in 1985, Ilene was editor of the Cleveland edition of TV Guide, associate editor of School Product News (Penton Publishing) and senior public relations representative at Beckman Instruments, Inc. She was profiled in a book, How to Open and Operate a Home-Based Writing Business and listed in Who's Who of American Women, Who's Who in Advertising and Who's Who in Media and Communications. She was the recipient of the Women in Communications, Inc. Clarion Award in advertising. A graduate of the University of Pennsylvania, Ilene and her family have lived in Irvine, California, since 1978.
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