European Commission grants conditional approval for Adcetris

Millennium, a wholly owned subsidiary of Japan’s largest drugmaker Takeda Pharmaceutical (TYO: 4502) says that the European Commission has granted conditional marketing authorization for Adcetris (brentuximab vedotin) for two indications.

The drug is under development with US biotech firm Seattle Genetics (Nasdaq: SGEN), triggering a $25 million milestone payment to the latter. Takeda intends to launch brentuximab vedotin across Europe, with the first launches planned in the coming weeks.

These indications are for the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, and for the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL). Granting of conditional marketing authorization by the EC means that there are specific obligations to provide additional clinical data at a later stage to confirm the positive benefit-risk balance, Takeda explained.