The EMA rejects XBiotech’s cancer drug after an embarrassing PhIII — but they’re not giving up
You can file this story in the Not Surprised folder.
Austin-based XBiotech’s application to start selling its lead cancer therapy has been spurned by European regulators.
That couldn’t have been completely unexpected as their lead drug — Xilonix — had offered up some dubious data. Investigators reported that the Phase III was marred by a mixup in treating the placebo and drug arms, a number of dropouts and improper patient evaluations. Investigators then used a surrogate endpoint on conserving patients’ health status as a measure of Phase III success.
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