(By Balachander) Celgene Corp. (NASDAQ:CELG) said it will request a re-examination of the negative opinion by a committee of European health authorities regarding the Marketing Authorisation Application (MAA) for Istodax(romidepsin) to treat peripheral t-cell lymphoma (PTCL).
A review by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) acknowledged that romidepsin showed anti-tumor activity, the Summit, New Jersey-based biopharmaceutical company noted.
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 said.
Celgene said it remains "convinced of the favorable benefit/risk profile" of romidepsin.
Istodax is approved in the United States for the treatment of patients with cutaneous t-cell lymphoma (CTCL) who have received at least one prior systemic therapy. Istodax is also approved in the United States for the treatment of patients with peripheral t-cell lymphoma (PTCL) who have received at least one prior therapy.
The stock, which has been trading between $51.70 and $80.42 over the past year, retreated 1.71 percent to trade at $66.82 on Friday.