EMA grants marketing authorisation of aflibercept (ZaltrapT) for previously treated metastatic colorectal cancer

Source: BioSpace Area: News The European Commission (EC) has granted marketing authorisation for aflibercept (ZaltrapT) for use in combination with irinotecan/ 5-fluorouracil/ folinic acid (FOLFIRI) chemotherapy for the treatment of adults with metastatic colorectal cancer (MCRC) that is resistant to or has progressed after an oxaliplatin-containing regimen.   This decision was based on the efficacy and safety results of the multinational, phase III randomised controlled VELOUR trial (n=1,226). The study showed that in patients previously treated with an oxaliplatin containing regimen, adding aflibercept to FOLFIRI statistically significantly improved median survival (primary endpoint) from 12.06 months to 13.50 months (HR=0.817 (95% CI 0.714 to 0.935; p=0.0032).   [Editors note: aflibercept (EyleaT) injection is also licensed for the treatment of macular oedema following central retinal vein occlusion.]
Source: NeLM - News - Category: Drugs & Pharmacology Source Type: news