UPDATE: Celgene to Request Re-Examination of CHMP ISTODAX® (romidepsin) Opinion
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.
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