SGN-35, an antibody-drug conjugate, is in an ongoing pivotal trial under a special protocol assessment from the FDA for relapsed or refractory Hodgkin lymphoma. The designation allows the SGN-35 new drug application (NDA) to be considered for submission on a rolling basis, allowing the FDA to review sections of the NDA as they are completed.
Seattle Genetics plans to initiate a Phase II study of single-agent SGN-35 in approximately 55 patients with relapsed or refractory systemic anaplastic large cell lymphoma. In addition, the company plans to report data from an ongoing weekly dosing Phase I clinical trial of SGN-35 between May 29, 2009 and June 2, 2009.
Clay Siegall, president and CEO of Seattle Genetics, said: “Receiving fast track designation is another important component of our regulatory strategy for SGN-35, and a key step for this program. With our pivotal trial underway, we expect data in 2011. Our goal remains to submit an NDA in 2011 with potential commercial launch in 2012.”