Seattle Genetics ($SGEN) plots FDA app on promising PhIII cancer data

Seattle Genetics ($SGEN) took center stage at the American Society of Hematology meeting over the weekend as it detailed some stellar late-stage data on brentuximab vedotin and outlined its strategy for a quick application filing, a priority review and plans to start selling the cancer therapy later in 2011.

Seattle Genetics is in hot pursuit of an approval for a drug that combines an antibody that targets cancer and can deliver a high-dose blast of a cancer-killing agent. Because healthy tissue is spared, the developer believes the drug can do a better job at fighting cancer while reducing side effects. Its shares were buoyed by the latest data.

"Our goal would be to submit in the first quarter, have an accelerated review and be on the market in 2011," Seattle Genetics' Chief Executive Clay Siegall told Reuters. And the biotech will rely on pivotal trial data demonstrating that more than a third of the Hodgkin's lymphoma patients taking brentuximab vedotin--or SGN-35--achieved complete remission.

Seattle Genetics commanded swift enthusiasm for the drug more than two months ago when it initially revealed that three of every four patients in the study saw tumors shrink at least 50 percent. The full results unveiled at ASH included at least some tumor shrinkage for 94 percent of all 102 patients. Mid-stage results from an ALCL trial are due out on Tuesday.

Oppenheimer's Bret Holley said the data met expectations, adding that the low rate of side effects actually exceeded expectations. RBC Capital has estimated peak sales at $420 million.

- get the Seattle Genetics press release
- read the report from Reuters
- here's the Bloomberg report

ALSO: Onyx also captured the ASH spotlight with the news that most multiple myeloma patients in a Phase IIb study of carfilzomib did not experience an increase in peripheral neuropathy - a common side effect from other drugs now in use. Onyx plans to seek regulatory approval for the drug next year. Story

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