As trumpeted in Xconomy and Fierce Biotech this morning, Seattle Genetics "empowered antibody" therapy for Hodgkin's disease sailed through its last pivotal trial with flying colors. Brentuximab vedotin (aka SGN-35) was able to partially or completely shrink tumors for 75 percent of the 102 patients with Hodgkin's disease. As a point of reference, most cancer drugs succeed in shrinking tumors in about 30% of the participants receiving the drug.
Seattle Genetics (and its partner Millenium) is now in position to seek approval from the FDA. SGN-35 would be the first licensed antibody drug conjugate or empowered antibody to be approved. Empowered antibodies are seen as a new and growing area in the treatment of various types of cancer. Genetech's T-DM1 is another such therapy that is deep into clinical trials for breast cancer.
"We are positioned for a Biologics License Application submission to the U.S. Food and Drug Administration in the first half of 2011," said CEO Clay Siegall. “I’ve been doing cancer research and making cancer drugs for 25 years, and these are the kind of data you dream of. We are going to have an amazing impact on patients.”
Posted by Bruce Lehr September 27th 2010.