Seattle Genetics’ FDA Panel Preview: What You Need to Know This Week

Xconomy Seattle — 

[Updated: 6:50 am PT] This is the week Seattle Genetics, a 14-year-old company, will have its biggest coming-of-age experience on its way to becoming a real grown-up.

The company (NASDAQ: SGEN) is getting ready to make its best possible argument for FDA approval of its new “empowered antibody” drug aimed at a pair of rare lymphomas. The evidence so far for this treatment, brentuximab vedotin (Adcentris), was posted in staff briefing documents on the FDA website, in advance of an FDA advisory committee meeting of cancer drug experts on Thursday in Silver Spring, MD.

The FDA panel’s review represents a huge moment for Seattle Genetics, and also could send a ripple effect through the biotech industry, and the Northwest’s local biotech cluster. If Seattle Genetics can persuade the expert panel to recommend its drug, and the FDA formally approves the treatment by its Aug. 30 deadline, then it will be the company’s first marketable product after spending 14 years and more than $500 million. It will also clear the way for what could be the first commercial success with a “smart bomb” antibody that zeroes in on tumors, while unleashing a potent toxin that hits the cancer and mostly spares healthy tissues.

For Seattle’s biotech community, it would mark the second time in two years that a local company has been able to blaze a trail with a new class of cancer drug, following last year’s FDA approval of an immune-boosting cancer fighter from Dendreon (NASDAQ: DNDN). And while about two-thirds of the 8,500 patients diagnosed in the U.S. with Hodgkin’s disease are successfully treated with chemotherapy, one-third eventually get relapsed, treatment-resistant forms that provide a grim prognosis-a life expectancy of just two to three years. If Seattle Genetics can win approval, it will start selling the first new drug for Hodgkin’s since 1977.

Eric Dobmeier

“We think this is very important for the industry and for cancer patients,” says Eric Dobmeier, Seattle Genetics’ chief operating officer. The combination of antibodies fused to potent toxins, sometimes called antibody-drug-conjugates, “have the potential to impact the way many cancers are treated. They are more targeted, and less toxic than chemotherapy,” Dobmeier says.

The evidence from clinical trials that Seattle Genetics has put together is “spectacularly positive,” says David Miller, president of Biotech Stock Research, an independent research firm. Seattle Genetics has been careful not to get overly confident in its public statements, but Dobmeier did say in an interview last week, “we believe we are on strong ground.” The debate, Miller says, is most likely to hinge on which specific patient populations ought to be included in the prescribing information.

The FDA and its expert panel are looking at data from more than 300 patients in clinical trials, and especially at two late-stage studies for Hodgkin’s lymphoma and … Next Page »

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