Cancer drugs typically don't work on all patients. Most work on less than half of the patients they treat, and as you get farther along in the disease progression, the number of patients that are helped go down substantially.
That's what makes Seattle Genetics
Seattle Genetics is up more than 18% on the news, even though positive results were already expected. In previous trials, the drug showed a response rate in the 50% to 60% range.
Seattle Genetics and marketing partner Takeda Pharmaceutical expect to use the data to file for Food and Drug Administration approval in the first half of next year. Given the unmet need, I'd expect a priority review, which would result in a six-month review and an approval before the end of next year.
Everything isn't ideal with the brentuximab vedotin results, though. The trial was relatively small -- just 102 patients -- and there was no placebo control to compare the results with. The FDA usually wants two well-controlled trials to approve a drug, but does have a mechanism -- called an accelerated approval -- for drugs that seem to be working on diseases with unmet needs.
Given the poor prognosis for these patients, the company had previously said that a 25% to 30% response rate would likely be good enough for approval. Brentuximab vedotin blew past that, so a thumbs-up seems likely.
Investors may be a little skittish after Roche and ImmunoGen
The bigger risk for Seattle Genetics investors is that brentuximab vedotin might fail follow-up trials that the FDA requires -- like Pfizer's
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