Seattle Genetics has completed enrollment in 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.
Reportedly, the brentuximab vedotin pivotal trial is a single-agent, single-arm study evaluating 100 patients with relapsed or refractory Hodgkin lymphoma, who previously received autologous stem cell transplant.
The primary endpoint of the study is objective response rate assessed by independent review. Secondary endpoints include duration of response, progression-free survival, overall survival and tolerability.
Clay Siegall, president and CEO of Seattle Genetics, said: “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.”
“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 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 US in the second half of 2011, with potential European launch to follow,” he added.