EMA gives thumbs-down to GSK's mul­ti­ple myelo­ma drug, PTC's Duchenne can­di­date

Mul­ti­ple myelo­ma drug Blenrep and Duchenne mus­cu­lar dy­s­tro­phy ther­a­peu­tic Translar­na did not make the Eu­ro­pean Med­i­cines Agency’s cut for full mar­ket­ing au­tho­riza­tion, the agency an­nounced Fri­day.

The EMA’s Com­mit­tee for Med­i­c­i­nal Prod­ucts for Hu­man Use (CHMP) rec­om­mend­ed against re­new­ing the con­di­tion­al mar­ket­ing au­tho­riza­tion for GSK’s Blenrep (be­lan­tam­ab mafodotin) for late-stage bone mar­row can­cer. The drug first re­ceived con­di­tion­al mar­ket­ing au­tho­riza­tion in 2020. Blenrep is used for pa­tients with wors­en­ing can­cer who have had at least four pre­vi­ous treat­ments.

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