Seattle Genetics ($SGEN) and its partner Takeda will have a mother lode of potential revenue on the line next week when it unveils data from two studies of SGN-35, a targeted, combination cancer therapy that is angling for the lead in a hot race with Roche's T-DM1 to become the first such new therapy on the market. Seattle Genetics CEO Clay Siegall tells Bloomberg that the developer is planning to file its app on SGN-35 in the first half of 2011, hoping for an approval before investigators can lock down confirmatory data from late-stage studies.
Roche, of course, tried and failed to convince the FDA that it should extend a quick approval of T-DM1 for breast cancer ahead of late-stage trial data. But the agency notes that a number of therapies are already available for that condition. Now Roche is planning to make a new attempt to gain an approval in 2012, giving Seattle Genetics an opening to get to the market a year ahead of the pharma giant.
As Bloomberg explains, the new combo drugs rely on an antibody, a toxic cancer-killing agent and a linker device to hold the two together as they make their way to the target. The antibody finds the target, the linker loosens its grip and the payload is dumped on the spot, saving healthy tissue that is currently at risk during chemo and allowing clinicians to apply higher doses of cancer drugs. And there are a number of these cancer drugs in the pipeline.
"If this approach pans out, it could bring a real change in the way we think about delivering treatment," breast cancer specialist Hope Rugo tells the business news service. "It's a perfect scenario for how you could kill cancer and not cause so much systemic toxicity."
- here's the article from Bloomberg