2012 Innovation in Biopharmaceuticals: Seattle Genetics
it took 13 years for Adcetris to gain initial approval from the Food and Drug Administration, but doctors treating Hodgkin’s lymphoma have been waiting more than 30 years for a new drug therapy. Trials of the new pharmaceutical from Seattle Genetics suggest it can benefit those for whom established therapies have failed.
Hodgkin’s lymphoma (HL) affects a relatively small population—about 8,500 each year are diagnosed in America with the cancer originating from white blood cells—but the effects can be devastating. Chronic fevers and back pain that accompany the swelling of lymph nodes are often suffered by those who would otherwise be in the prime of their lives. Even with aggressive chemotherapy, nearly a third of HL patients relapse and might undergo a difficult transplant of stem cells from their own bone marrow.
The FDA granted Adcetris (brentuximab vedotin) accelerated approval in August 2011. This category requires additional confirmatory trials, and Seattle Genetics has nine ongoing or planned clinical trials for the drug, which thus far has been able to shrink tumors in 75 percent of relapsed or refractory patients with HL and in 86 percent of patients with ALCL, a similarly aggressive lymphoma.
The approval has been a milestone for Seattle Genetics, which has been working on targeted cancer therapies since its founding in 1998. Based on Seattle Genetics’ antibody drug conjugate (ADC) technology, Adcetris targets the cell surface protein called CD30 found in HL, ALCL and other cancers.
Seattle Genetics and its partner affiliates saw sales of $10 million in its first six weeks—more than five times better than the expectations of Wall Street analysts. By 2014, Adcetris may account for $275 million in annual sales, according to an average of analyst projections. More to the point: Adcetris offers significant hope for some patients who would have otherwise run out of options, and the success of the technique suggests possible treatments for other cancers as well.
Building on a history of biotechnology leadership in Seattle, Amgen released Prolia (denosumab), a bone-loss therapy drug and the first of its kind, in 2010. While Prolia can treat postmenopausal women at risk for fracture, in 2011, the FDA also approved its sister drug, Xgeva, for use in cancer patients undergoing hormone therapy. A decade after acquiring Seattle pharmaceutical company Immunex, Amgen continues to lead the industry with its science-driven product development. The research and development of Xgeva took place in Seattle, and in clinical trials the drug delayed skeletal-related events by five months compared to the customary treatment. — Sarah Dewey