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FDA Breakthrough Therapy Designation: Syndax Pharma Receives 21st

September 11, 2013

Syndax Pharmaceuticals, a Massachusetts company developing epigenetic therapies for treatment-resistant cancers, announces on September 11, 2013, that non-orphan drug Entinostat receives FDA Breakthrough Therapy Designation (BTD). BTD #21 is for Entinostat for the treatment of :

“.. locally recurrent or metastatic Estrogen Receptor-Positive (ER+) breast cancer when added to Exemestane in postmenopausal women whose disease has progressed following non-steroidal aromatase inhibitor therapy”.

The BTD for Entinostat is based on data from a completed Phase II study (ENCORE 301). This study shows that Entinostat extends both Progression-Free Survival (PFS) and overall survival when added to Exemestane in postmenopausal women with ER+ metastatic breast cancer.

Entinostat, an oral, highly selective Histone Deacetylase (HDAC) inhibitor, is Syndax Pharmaceuticals’ lead product candidate. The company holds worldwide rights to Entinostat. In the first quarter of 2014, a Phase III trial is planned to begin enrolling patients. NCI (National Cancer Institute) and Syndax Pharmaceuticals are collaborating on the development of Entinostat under a Cooperative Research and Development Agreement, with the purpose of “improving survival in advanced, hard-to-treat cancers”.

In April 2013, Pfizer’s drug Palbociclib receives FDA BTD for the potential treatment of patients with breast cancer. Palbociclib is being evaluated as an initial treatment for the biggest subgroup of postmenopausal women whose breast cancer is locally advanced or has spread elsewhere in the body. Approximately 60-70% of women with this type of advanced breast cancer have tumors that are ER+ (Estrogen-Receptor Positive).

The latest “FDA Breakthrough Therapy Designation Chart” Blog Post, is located at URL http://wp.me/p2w211-1mO, so please bookmark.

The latest “FDA Breakthrough Therapy Designation Statistics Chart” Blog Post is located at URL http://wp.me/p2w211-1tA, so please bookmark.

References

Syndax Pharmaceuticals Pipeline

Please Note: FDA Official Logo from FDA website.

Copyright © 2012-2013, Orphan Druganaut Blog. All rights reserved.

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