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EC Clears Expanded Use of Novartis' Zykadia for First Line NSCLC Therapy

05:45 EDT 29 Jun 2017 | Genetic Engineering News

The European Commission approved the expanded use of Novartis’ Zykadia ® (ceritinib) to include first-line treatment of advanced non-small-cell lung cancer (NSCLC) in patients with anaplastic lymphoma kinase (ALK)-positive tumors . "Today's EC approval of Zykadia as a first-line treatment of ALK-positive NSCLC is an important step forward for patients with this type of serious disease," said Bruno Strigini, Pharm.D., CEO, Novartis Oncology. "Our commitment to innovation in lung cancer will continue and we look forward to providing additional advancements for patients as the incidence of the disease grows around the world." Last month FDA approved the ALK-inhibitor Zykadia as first-line therapy for ALK-positive NSCLC following confirnation by an FDA-approved test. Expanded use of Zykadia as first-line therapy for ALK-positive NSCLC in Europe and in the U.S., was based on data from the Phase III ASCEND-4 study in 376 previously untreated adult patients with stage IIIB or ...

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