- Written by Dr. Cheryl Strelko, Oncology Analyst for GlobalData.
On August 3, 2012, Sanofi and Regeneron announced the FDA approval of their oncology drug Zaltrap (ziv-aflibercept). After the FDA granted it priority review, Zaltrap has been approved for use in combination with 5-fluorouracil, leucovorin and irinotecan (FOLFIRI) for patients with metastatic colorectal cancer (mCRC) whose disease has progressed following prior treatment with Sanofi’s Eloxatine (oxaliplatin). The FDA approval was based on results from the 1226-patient Phase III VELOUR trial, which indicated that Zaltrap/FOLFIRI combination therapy increased the median overall survival of patients by 1.44 months compared to patients treated with a placebo and FOLFIRI (13.50 months versus 12.06, respectively). Additionally, the Zaltrap/FOLFIRI combination therapy improved the median progression-free survival to 6.9 months compared to 4.67 months in patients taking placebo/FOLFIRI. Sanofi also filed for marketing approval by the European Medicines Agency in Q4 2011; a decision is expected in late Q4 2012.