The European Medicines Agency has granted Takeda Pharmaceutical (TYO: 4502) a label extension for Adcetris (brentuximab vedotin) to include the treatment of certain people with Stage IV Hodgkin lymphoma, in combination with chemotherapy.
The decision was widely anticipated, after the European regulator’s advisory panel recommended approval in late 2018.
The approval was based on results from the Phase III ECHELON-1 trial, which met its primary endpoint, showing a statistically-significant improvement in modified progression-free survival.
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