Verastem, Inc., (VSTM: Quote) said it received orphan drug designation from the U.S. Food and Drug Administration for lead cancer stem cell inhibitor, VS-6063 (defactinib), for use in the treatment of mesothelioma, a rare form of lung cancer.
Robert Forrester, Verastem President and Chief Executive Officer. "We are pleased that the FDA recognizes the significant unmet medical need in mesothelioma. We previously received orphan medicinal product status for defactinib in Europe and these two designations are an important component of our development strategy."
Verastem recently outlined details of the registration-directed clinical study of defactinib in patients with malignant pleural mesothelioma. This study is designed as a double-blind, placebo-controlled trial with an expected enrollment of approximately 350-400 patients at clinical sites in 11 countries.
Orphan drug designation is granted by the FDA Office of Orphan Drug Products to novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S. The designation provides eligibility for a seven-year period of market exclusivity in the U.S. after product approval, FDA assistance in clinical trial design, and an exemption from FDA user fees.
 |
|
by RTT Staff Writer
For comments and feedback: editorial@rttnews.com
Business News
0 comments:
Post a Comment