Af­ter tak­ing a look at new da­ta, reg­u­la­tors put J&J's BC­MA/CD3 bis­pe­cif­ic on a 'break­through' track

Af­ter of­fer­ing a peek at the up­dat­ed da­ta it’s bring­ing to AS­CO next week, J&J is mov­ing in­to the fast lane with its BC­MA/CD3 bis­pe­cif­ic an­ti­body for pre­vi­ous­ly treat­ed mul­ti­ple myelo­ma pa­tients who are short on oth­er op­tions.

Reg­u­la­tors have grant­ed break­through ther­a­py des­ig­na­tion to teclis­tam­ab, which is now in Phase II for re­lapsed or re­frac­to­ry mul­ti­ple myelo­ma, Janssen said Tues­day. The agency based its de­ci­sion on da­ta from the Phase I Ma­jesTEC-1 tri­al, in which 65% of 40 pa­tients who re­ceived the rec­om­mend­ed Phase II dose saw a re­sponse.

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