J&J's BC­MA/CD3 bis­pe­cif­ic nabs a con­di­tion­al EMA nod, jump­ing in front of FDA

The Eu­ro­pean Med­i­cines Agency (EMA) has rec­om­mend­ed a con­di­tion­al mar­ket­ing au­tho­riza­tion for J&J’s mul­ti­ple myelo­ma drug teclis­tam­ab, a BC­MA/CD3 bis­pe­cif­ic an­ti­body, which hasn’t been FDA ap­proved in the US.

The rec­om­men­da­tion will help pa­tients in the EU with re­lapsed and re­frac­to­ry mul­ti­ple myelo­ma, who have re­ceived at least three pri­or ther­a­pies and whose can­cer has wors­ened since re­ceiv­ing the last treat­ment. J&J will brand the drug as Tec­vayli in the EU.

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