Regulators signaled a new pathway for multiple myeloma drug development by issuing draft guidance that permits measurable residual disease (MRD) negativity and complete response rates to support accelerated approval in some cases. The FDA’s draft—detailed in BioCentury reporting—lays out how sponsors can use MRD as a surrogate endpoint for accelerated approval when linked to clinical benefit and validated assays. Industry figures including J&J welcomed the move, saying it could change trial design and shorten timelines for cell therapies and novel agents. Sponsors must still provide confirmatory trials to convert accelerated approvals to full approvals.