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news.Seattle Genetics, a biotechnology company, has reached agreement with the FDA on a special protocol assessment for a pivotal trial of SGN-35, an antibody-drug conjugate, for patients with relapsed or refractory Hodgkin lymphoma.
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The special protocol assessment (SPA) provides an agreement between the FDA and Seattle Genetics regarding the design, including size and clinical endpoints, of the pivotal trial to support an efficacy claim in a new drug application (NDA).
The single-arm pivotal trial will assess efficacy and safety of single-agent SGN-35 in 100 patients with relapsed or refractory Hodgkin lymphoma who previously received autologous stem cell transplant. Patients will receive 1.8mg/kg of SGN-35 every three weeks.
The primary endpoint of the trial will be objective response rate assessed by an independent radiographic facility. Secondary endpoints include duration of response, progression-free survival, overall survival and tolerability. The company plans to enroll patients at more than 30 sites in the US, Canada and Europe.
Seattle Genetics also plans to conduct a Phase II study of single-agent SGN-35 in approximately 50 patients with relapsed or refractory systemic anaplastic large cell lymphoma, which is also expected to begin in the first quarter of 2009.
Clay Siegall, president and CEO of Seattle Genetics, said: Reaching this agreement with the FDA on an SPA for Hodgkin lymphoma is an important part of our regulatory strategy for SGN-35 and positions us to initiate the pivotal trial in the first quarter of 2009. Our goal is to submit an NDA in 2011 under the accelerated approval regulations.