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news.Seattle Genetics and the Takeda Oncology Company, Millennium, have released positive top-line results from the pivotal single-agent Brentuximab vedotin (SGN-35) trial.
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SGN-35 is an antibody-drug conjugate (ADC) targeted to CD30.
In the trial, 75% of the patients achieved an objective response as assessed by an independent central review, the primary endpoint of the trial.
The median duration of response was greater than six months. The safety profile of Brentuximab vedotin in this trial was generally consistent with prior clinical trial experience.
Seattle Genetics president and CEO Clay Siegall said that thhe are positioned for a biologics license application (BLA) submission to the US Food and Drug Administration (FDA) in the first half of 2011.
“In addition, we plan to report top-line data from our phase II trial of brentuximab vedotin in patients with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) within the next few weeks,” Siegall said.
Millennium chief medical officer Nancy Simonian said that these data have the potential to provide an important advance in therapy for Hodgkin lymphoma. We intend to discuss these results with European regulators to support our goal of submitting a Marketing Authorisation Application to the European Medicines Agency (EMA) in 2011.