Celgene International Sárl to Request Re-Examination of CHMP ISTODAX® (romidepsin) Opinion

BOUDRY, Switzerland--(BUSINESS WIRE)--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).

Back to news