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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