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 Siegall. "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 within the next few weeks."
Seattle Genetics' shares (SGEN) were surging this morning in pre-market trading. The news was also a plus for Millennium, which is partnered on the program and has ex-U.S. and Canada rights to the therapy. Millennium, a subsidiary of Takeda, paid $60 million upfront and offered $230 million in milestones to partner on the therapy.
- see the Seattle Genetics release
- check out the story from Forbes