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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