Im­munomedics spells out PFS ben­e­fit of Trodelvy in mTNBC, hunt­ing a full OK just weeks af­ter ac­cel­er­at­ed ap­proval

By the time the FDA fi­nal­ly grant­ed an ac­cel­er­at­ed OK for Im­munomedics’ Trodelvy, we al­ready got a very strong hint that their con­fir­ma­to­ry Phase III study in metasta­t­ic triple-neg­a­tive breast can­cer was a suc­cess.

That’s be­cause the in­de­pen­dent da­ta safe­ty mon­i­tor­ing com­mit­tee rec­om­mend­ed that the tri­al be stopped ear­ly. But just what point­ed them to the con­clu­sion was still un­clear.

“We do not know the to­tal­i­ty of their de­ci­sion oth­er than it’s pret­ty ev­i­dent that the pri­ma­ry end­point was met; oth­er­wise they could not re­quest to halt the study,” Be­hzad Ag­haz­adeh, the ex­ec­u­tive chair­man, told End­points News at the time.

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