ARTICLE | Clinical News

Entinostat: SPA received

February 17, 2014 8:00 AM UTC

Syndax said FDA granted an SPA for a Phase III trial to evaluate entinostat in combination with Aromasin exemstane in postmenopausal women with advanced estrogen receptor-positive breast cancer who have progressed on a non-steroidal aromatase inhibitor. Syndax said that FDA has agreed on the use of either PFS or OS as primary endpoints for the basis of an NDA submission. The trial, which is slated to begin this half, is being conducted by the ECOG-ACRIN Cancer Research Group under sponsorship by the Division of Cancer Treatment and Diagnosis (DCTD) of the National Cancer Institute (NCI).

Last year, FDA granted breakthrough therapy designation to entinostat to treat locally recurrent or metastatic estrogen receptor-positive breast cancer when added to exemestane in postmenopausal women whose disease has progressed following non-steroidal aromatase inhibitor therapy. Syndax has exclusive, worldwide rights to develop and commercialize entinostat from Bayer (see BioCentury, April 16, 2007). ...