Celgene (CELG) Unit to Request Re-Examination of Negative Opinion on ISTODAX from EMA CHMP
Tweet Send to a FriendGet Alerts CELG Hot Sheet
Up)
Trade CELG Now!
Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ: CELG) today announced it will request a re-examination of the negative opinion announced by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) regarding the Marketing Authorisation Application (MAA) submitted for ISTODAX® (romidepsin) for the treatment of relapsed or refractory peripheral t-cell lymphoma (PTCL).
During the regulatory review process, it was acknowledged that romidepsin demonstrated anti-tumor activity, however, in the absence of a reference treatment in the clinical trial submitted to support the application, the committee was unable to agree that the benefit/risk relationship of romidepsin was demonstrated.
Celgene remains convinced of the favorable benefit/risk profile of romidepsin, which has the potential to offer an important new treatment option in this area of high unmet medical need in the EU, where no agents are currently approved. The company will therefore, in accordance with European regulations, request a re-examination of the CHMP opinion.
Patients will continue to have access to romidepsin through clinical studies and in the EU under a named patient program (NPP) where available.
Join StreetInsider.com FREE and get immediately alerted when news breaks on your stocks and other market items - JOIN NOW
*NEW - Download StreetInsider's FREE iPhone and iPad App - Click Here
During the regulatory review process, it was acknowledged that romidepsin demonstrated anti-tumor activity, however, in the absence of a reference treatment in the clinical trial submitted to support the application, the committee was unable to agree that the benefit/risk relationship of romidepsin was demonstrated.
Celgene remains convinced of the favorable benefit/risk profile of romidepsin, which has the potential to offer an important new treatment option in this area of high unmet medical need in the EU, where no agents are currently approved. The company will therefore, in accordance with European regulations, request a re-examination of the CHMP opinion.
Patients will continue to have access to romidepsin through clinical studies and in the EU under a named patient program (NPP) where available.
Join StreetInsider.com FREE and get immediately alerted when news breaks on your stocks and other market items - JOIN NOW
*NEW - Download StreetInsider's FREE iPhone and iPad App - Click Here
You May Also Be Interested In
- Celgene (CELG) Granted FDA Priority Review for ABRAXANE sNDA in Advanced Pancreatic Cancer
- Cardiovascular Systems (CSII) ORBIT II Trial Met Endpoints
- Janssen Pharma (JNJ) Plans Slew of Filing, Extension Submissions by FY17
Create E-mail Alert Related Categories
Corporate News, FDA
Login with Facebook
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!
