New Products, Regulatory

FDA hands Seattle Genetics its 5th OK for Adcetris. But can they actually sell it for frontline Hodgkin lymphoma?

As expected, the FDA has come through with their 5th approval for Seattle Genetics’ $SGEN Adcetris. And now the company can start to prove whether they can squeeze some additional revenue out of it.

Clay Siegall

At ASH last fall Seattle Genetics CEO Clay Siegall was adamant that the two-year modified progression-free survival rate of 82.1% compared to 77.2% in the control arm of the ECHELON-1 frontline Hodgkin lymphoma study — a 4.9 point, or 6%, improvement — would get physicians’ attention.

More patients would be given an opportunity to find a curative solution, said Siegall, even though there was no significant overall survival benefit in the data package for the combination of Adcetris and chemo. And patients could drop the toxic bleomycin from the standard chemo combo used to treat the disease.

Analysts tended to diss the results as relatively modest, and lymphoma expert John Leonard noted at the time that most patients will be able to drop bleomycin after the second cycle in any case, citing a study called RATHL.

Some analysts, though, are confident nevertheless that the 5th OK for Adcetris will move the franchise drug ever closer to blockbuster status, helping fund the rest of the R&D work now underway at the company.

“We think there’s a strong value proposition across the board,” Siegall told me at ASH. “It is what payers are covering.”

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Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
Director of Operations
Atlas Venture Cambridge, MA

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