Array Biopharma (ARRY) Reaches Agreement with FDA on Phase 3 BEACON CRC SPA
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Array BioPharma Announces Phase 3 BEACON CRC SPA Agreement with FDA
September 14, 2016 7:30 AM EDTBOULDER, Colo., Sept. 14, 2016 /PRNewswire/ -- Array BioPharma (Nasdaq: ARRY) announced today that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) related to BEACON CRC, a global Phase 3 trial of encorafenib and Erbitux® (cetuximab), with or without binimetinib, versus standard of care in patients with BRAF-mutant colorectal cancer (CRC) who have previously received first-or second-line systemic therapy. ... More