Fierce Pharma April 12, 2024
After oncology experts reviewed arguments in favor of a surrogate endpoint to support multiple myeloma drug approvals, drug developers may soon have a new pathway in the R&D journey.
Friday, 12 members of an FDA advisory committee voted unanimously to support the use of minimal residual disease (MRD) as a surrogate endpoint to enable accelerated approvals of new therapies in multiple myeloma.
Given the panel’s overwhelming support—and the FDA’s own positive review ahead of the meeting—the agency will likely start incorporating the approach in its regulatory practices soon.
Since surrogate endpoints in clinical trials read out faster than traditional clinical-outcomes endpoints such as progression-free survival (PFS) or overall survival (OS), new therapies could be expected to reach the market sooner...
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