Seattle Genetics' antibody-chemo cancer combo clears pivotal hurdle
Seattle Genetics has turned in a promising new batch of data on its antibody/chemo combo for Hodgkin's lymphoma and says it is now positioned to take a short cut to regulatory approval.
Seattle Genetics has turned in a promising new batch of data on its antibody/chemo combo for Hodgkin's lymphoma and says it is now positioned to take a short cut to regulatory approval. The biotech's drug, brentuximab vedotin, relies on an antibody to home in on a tumor and then drops its chemo payload right on the target. And in the latest trial the therapy shrank tumors in a whopping 75 percent of relapsed patients.
Matthew Herper at Forbes notes this morning that other drug developers have tried the same "smart bomb" approach to cancer only to fail badly. But Seattle Genetics believes that its small trial for brentuximab vedotin--which recruited 102 Hodgkin lymphoma patients--will pass muster at the FDA, which provided a Special Protocol Assessment that could make the therapy approvable with a limited data set.
"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 Siegal
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