Adcomm backs use of minimal residual disease in multiple myeloma accelerated approvals

A new on­col­o­gy drug end­point, based on what’s known as min­i­mal resid­ual dis­ease, gained the back­ing of FDA ad­vi­sors, po­ten­tial­ly open­ing the door to new tri­al de­signs for blood can­cer drugs.

An FDA ad­vi­so­ry com­mit­tee vot­ed unan­i­mous­ly on Fri­day that ev­i­dence sup­ports a new in­ter­me­di­ate end­point for ac­cel­er­at­ed ap­provals in mul­ti­ple myelo­ma.

Us­ing min­i­mal resid­ual dis­ease, or MRD, could shave years from time­lines for drugs to treat the can­cer, which is ex­pect­ed to be di­ag­nosed in more than 35,000 Amer­i­cans this year, ac­cord­ing to the Amer­i­can Can­cer So­ci­ety. Iron­i­cal­ly, the im­prove­ment of op­tions for mul­ti­ple myelo­ma pa­tients has made it hard­er to mea­sure the suc­cess of new drugs, ac­cord­ing to the FDA, since bet­ter stan­dards of care can stretch out the amount of time it takes — or num­ber of pa­tients re­quired — to mea­sure over­all re­sponse rates and pro­gres­sion-free sur­vival.

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