The European Commission has granted Takeda’s Adcetris (brentuximab vedotin) a conditional marketing approval for the treatment of certain lymphomas.
The decision means that the drug can be used to treat adult patients with: relapsed or refractory CD30 positive Hodgkin lymphoma following autologous stem cell transplant (ASCT) or at least two prior therapies when ASCT or multi-agent chemotherapy is not appropriate; or relapsed/refractory systemic anaplastic large cell lymphoma.
Adcetris (brentuximab vedotin) is a CD30-directed antibody-drug conjugate which was granted Orphan Drug status in Europe back in 2009.
According to Professor Andreas Engert, University Hospital of Cologne, Germany, the drug “has been shown to offer a high overall response rate, including durable complete responses in both of its indications”, and its approval “signifies an important advancement” in the treatment of patients with these rare blood cancers.
Takeda said it intends to start launching Adcetris across Europe within coming weeks.
But as per the terms of its conditional marketing authorisation, the company must supply additional clinical data at a later stage, in order to confirm the drug’s benefit-risk balance.
Adcetris was approved for use in the US in August last year, where it is marketed by Seattle Genetics.
