|Impressive results for Seattle Genetics|
|By Staff and Wire Reports|
|Monday, 27 September 2010 06:05|
Seattle Genetics, Inc. (Nasdaq: SGEN) announced this morning some positive top-line results from the pivotal trial of single-agent brentuximab vedotin (SGN-35), an antibody-drug conjugate. The trial was conducted in 102 relapsed or refractory Hodgkin lymphoma (HL) patients and its experimental cancer medicine shrank tumors in 75% of patients with Hodkin lymphoma that had relapsed despite rounds of chemotherapy and bone marrow transplants.
“We are extremely excited with the top-line results, as they move us one step closer to our goal of bringing brentuximab vedotin to patients with relapsed or refractory Hodgkin lymphoma,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “We are positioned for a Biologics License Application (BLA) submission to the U.S. 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.”
“The lack of adequate therapies for the treatment of relapsed and refractory Hodgkin lymphoma represents a substantial unmet medical need worldwide, with almost a third of the 30,000 newly diagnosed patients relapsing or becoming refractory to front-line therapy annually,” said Nancy Simonian, M.D., Chief Medical Officer of Millennium. “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 Authorization Application to the European Medicines Agency (EMA) in 2011.”
The announcement came very early this morning and the news was officially released by SGEN and Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (TSE:4502)
Historically, most drugs in this patient population only shrink tumors in only 30% of patients. Accodring to Mathew Herper of Forbes, If the study results in approval for brentuximab vedotin, it will also be proof that the FDA does sometimes approve drug based on small studies, or without placebo groups. There is no placebo group on the trial, and it involved only 102 patients.