THE FDA RECOGNIZES OS AS THE MOST RELIABLE AND PREFERRED CLINICAL ENDPOINT IN CANCER TRIALS5
References: 1. Cortes J, O’Shaughnessy J, Loesch D, et al; EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Physician’s Choice Versus E7389) investigators. Eribulin monotherapy versus treatment of physician’s choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study. Lancet. 2011;377(9769):914-923. 2. Testori A, Richards J, Whitman E, et al. Phase III comparison of Vitespen, an autologous tumor-derived heat shock protein gp96 peptide complex vaccine, with physician's choice of treatment for stage IV melanoma: the C0100-21 study group. J Clin Oncol. 2008;26(6):955-962. 3. Cree IA, Kurbacher CM, Lamont A, Hindley AC, Love S; TCA Ovarian Cancer Trial Group. A prospective randomized controlled trial of tumour chemosensitivity assay directed chemotherapy versus physician's choice in patients with recurrent platinum-resistant ovarian cancer. Anticancer Drugs. 2007;18(9):1093-1101.4. HALAVEN [package insert]. Woodcliff Lake, NJ: Eisai Inc; 2016. 5. U.S. Department of Health and Human Services, Food and Drug Administration. Guidance for Industry: Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics. http://www.fda.gov/downloads/Drugs/guidancecomplianceregulatoryinformation/guidances/ucm071590.pdf. Published May 2007. Accessed January 31, 2018.