DAVID GRANOVSKY

SGEN Seattle Genetics Finalizes Enrollment of Its Brentuximab Vedotin (SGN-35) Pivotal Trial

In BUSINESS OF STEM CELLS on August 26, 2009 at 3:47 am

Aug 25, 2009 (Close-Up Media via COMTEX) — SGEN | Quote | Chart | News | PowerRating — Seattle Genetics, Inc. announced that it has completed enrollment of its pivotal clinical trial of brentuximab vedotin (SGN-35) for relapsed and refractory Hodgkin lymphoma.

Brentuximab vedotin is an antibody-drug conjugate (ADC) targeted to CD30 utilizing the company's proprietary ADC technology.

“Strong interest in brentuximab vedotin from investigators and patients has allowed us to rapidly complete our target enrollment of 100 patients in the pivotal trial in six months, emphasizing the substantial unmet medical need in the relapsed and refractory Hodgkin lymphoma setting,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “The pivotal trial allows for patient treatment up to approximately one year, and we expect data to be available in the second half of 2010. Our goal is to submit both a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) under the accelerated approval regulations and a Marketing Authorization Application (MAA) with the European Medicines Agency (EMEA) for conditional marketing authorization in the first half of 2011. Assuming priority review of our NDA, we would then plan to commercially launch the drug in the United States in the second half of 2011, with potential European launch to follow.”

via SGEN Seattle Genetics Finalizes Enrollment of Its Brentuximab Vedotin (SGN-35) Pivotal Trial.

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