The US Food and Drug Administration (FDA) has approved ZALTRAP (ziv-aflibercept) injection to be used in combination with 5-fluorouracil, leucovorin, irinotecan (FOLFIRI) to treat patients with metastatic colorectal cancer (mCRC) that is resistant to an oxaliplatin-containing regimen.
Zaltrap is an angiogenesis inhibitor which inhibits the blood supply to tumors.
FDA has approved Zaltrap following a Priority Review and a data collected from the pivotal Phase III VELOUR trial, a multinational, randomized, double-blind trial.
Jefferson Medical College clinical professor of medicine and medical oncology and VELOUR pivotal study investigator Edith Mitchell said "The approval of ZALTRAP in combination with a FOLFIRI chemotherapy regimen offers another treatment option and is welcome news for metastatic colorectal patients and their physicians."
Regeneron Research Laboratories and Sanofi have jointly announced FDA approval.
Sanofi Oncology senior vice president and Head Debasish Roychowdhury said, "Colorectal cancer is one of the deadliest cancers and is responsible for more than half a million deaths globally each year.''
Regeneron Research Laboratories president and Regeneron chief scientific officer George Yancopoulos said, "The approval of the novel angiogenesis inhibitor ZALTRAP provides a new option to address the unmet medical need in this patient population.''
