CHMP gives positive opinion on variation to marketing authorization for Adcetris

The EMA’s Committee for Medicinal Products for Human Use adopted a positive opinion, recommending a change to the terms of the marketing authorization for the medicinal product Adcetris. The marketing authorization holder for this medicinal product is Takeda (TAK) Pharma A/S. The CHMP adopted a new indication to include treatment of adults with previously untreated CD30+ Stage IIB with risk factors, Stage III or Stage IV Hodgkin lymphoma, in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine, and dexamethasone.