BioCentury
ARTICLE | Clinical News

Adcetris brentuximab vedotin regulatory update

July 23, 2012 7:00 AM UTC

EMA's CHMP recommended conditional approval of an MAA from Takeda for Adcetris brentuximab vedotin for relapsed or refractory CD30-positive Hodgkin's lymphoma following autologous stem cell transplant (ASCT) or following at least 2 prior therapies when ASCT or multi-agent chemotherapy is not a treatment option. CHMP also recommended conditional approval of the product for relapsed or refractory systemic anaplastic large cell lymphoma (ALCL). The product is an antibody-drug conjugate (ADC) composed of an anti- CD30 mAb and monomethyl auristatin E (MMAE). ...