EC ex­pands ap­proval of Am­gen's Blin­cy­to; FDA gives uniQure green sig­nal to be­gin Hunt­ing­ton's study in hu­mans, Cy­to­ki­net­ics feed­back on SMA tri­al

→ The first ther­a­py to win ap­proval for can­cer pa­tients in re­mis­sion with min­i­mal resid­ual dis­ease in Eu­rope is Am­gen‘s $AMGN BiTE im­munother­a­py, Blin­cy­to. The drug’s EC ap­proval has been ex­pand­ed to in­clude cer­tain pa­tients with acute lym­phoblas­tic leukemia in first or sec­ond com­plete re­mis­sion with min­i­mal resid­ual dis­ease (MRD) – the pres­ence of can­cer cells that re­main de­tectable de­spite re­mis­sion – greater than or equal to 0.1%. The EC ap­proval is based on da­ta from the Phase II BLAST study, which demon­strat­ed the drug led to no de­tectable MRD, in 78 per­cent of pa­tients with­in one treat­ment cy­cle. The EC nod fol­lows a sim­i­lar FDA ap­proval last March.

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