Adcetris Earns Conditional Approval in Europe
European regulators have granted conditional approval to Seattle Genetics to begin marketing Adcetris (brentuximab vedotin) in member countries in the EC.
Regulators have approved Adcetris for two indications:
-- The treatment of adults with relapsed or refractory CD30-positive Hodgkin's lymphoma (HL) following autologous stem cell transplant (ASCT) or at least two prior therapies when ASCT or chemotherapy aren’t appropriate
-- The treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL)
Adcetris was granted accelerated approval in the United States in August of 2011, which means that Seattle Genetics is required to provide added clinical trial data to confirm the risk-benefit assessment of the treatment.
In Europe it will be no different since the EC's conditional marketing authorization requires much the same things as accelerated approval in the U.S.
Adcetris is an antibody drug conjugate (ADC) that includes an anti-CD30 monoclonal antibody attached to the cytotoxic microtubule disrupting agent monomethyl autistatin E.
Source: Seattle Genetics
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