Liv­er tox cas­es force Dai­ichi Sankyo to cur­tail re­cruit­ment for PhI­II tri­al of a ‘break­through’ drug

Two cas­es of se­ri­ous liv­er tox­i­c­i­ty forced in­ves­ti­ga­tors to sus­pend en­roll­ment on Dai­ichi Sankyo’s Phase III pro­gram for its “break­through” drug pex­i­dar­tinib (PLX3397). But both cas­es were non-fa­tal, a com­pa­ny spokesper­son tells End­points News, and the tri­al is head­ed to com­ple­tion af­ter the com­pa­ny de­cid­ed to wrap en­roll­ment a few sub­jects short of their goal.

Dai­ichi Sankyo is test­ing the drug on rare cas­es of tenosyn­ovial gi­ant cell tu­mor (TGCT) among pa­tients who couldn’t qual­i­fy for sur­gi­cal re­moval of the tu­mor. By the time the liv­er tox is­sues ap­peared, the com­pa­ny had al­ready en­rolled 121 of the planned 126 pa­tients and the da­ta mon­i­tor­ing com­mit­tee sug­gest­ed cut­ting en­roll­ment short and tak­ing mea­sures so they could pre­serve the study as a dou­ble-blind­ed test.

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