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Syndax Announces NCI and FDA Reach Agreement on a Special Protocol Assessment (SPA) for the Phase 3 Trial of Entinostat in Patients with Advanced ER+ Breast Cancer

WALTHAM, Mass., Feb. 13, 2014 – Syndax Pharmaceuticals, Inc., today announced that the Division of Cancer Treatment and Diagnosis (DCTD) of the National Cancer Institute (NCI) has reached a special protocol assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) for the planned pivotal Phase 3 trial of entinostat in patients with advanced breast cancer. The Phase 3 trial, expected to begin i n the first half of this year, is intended to evaluate entinostat in combination with exemestane in postmenopausal patients with advanced estrogen receptor-positive (ER+) breast cancer who have progressed on a non-steroidal aromatase inhibitor. The study is being conducted by the ECOG-ACRIN Cancer Research Group under the sponsorship of the DCTD. DCTD, NCI is sponsoring the trial as part of the development of entinostat under a Cooperative Research and Development Agreement between NCI and Syndax.