Seattle Genetics, Takeda Pharmaceutical Company and its wholly owned subsidiary Millennium announced the beginning of the Phase III trial of brentuximab vedotin for post-transplant Hodgkin lymphoma patients.
The randomised, double-blind, placebo-controlled Phase III trial will evaluate brentuximab vedotin, an antibody-drug conjugate, against the placebo for the treatment of patients with a high risk of residual Hodgkin lymphoma.
The Phase III trial will be conducted in about 325 patients in the US, Europe and Russia.
A pivotal trial, designed to form the basis for registration filings with the US FDA and EMA, is in progress in relapsed and refractory Hodgkin lymphoma, and the data is expected in the second half of 2010.
The regulatory filings are expected in the first half of 2011.
Seattle Genetics is developing the drug in collaboration with Millennium, under which the former has the US and Canadian commercialisation rights, and the Takeda Group has rights for the rest of the world.
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Seattle Genetics and the Takeda Group are funding joint drug development costs on a 50:50 basis, except in Japan where the latter will be solely responsible for the costs.