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Frontline Alectinib Recommended for EU Approval for ALK+ NSCLC

Jason Harris
Published: Friday, Oct 13, 2017

Dr. Sandra Horning
Sandra Horning, MD
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of alectinib (Alecensa) for the first-line treatment of adults with ALK-positive, advanced non–small cell lung cancer (NSCLC).

The most common grade ≥3 AEs (≥5%) in the alectinib arm were increased alanine transferase and aspartate transferase (5%) and decreased red blood cells (5%). Patients assigned to crizotinib were more likely to discontinue treatment due to AEs (13% vs 11%), and more likely to experience dose reduction (21% vs 16%) and dose interruption (25% vs 19%).
CHMP recommends EU approval of Roche’s Alecensa (alectinib) as a first-line treatment for people with ALK-positive NSCLC. Roche. Accessed October 13, 2017.

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