Minimal Residual Disease Speeds Up Myeloma Drug Approvals
Bristol Myers Squibb’s Nathan Pennell says MRD is cutting regulatory wait times for multiple myeloma drugs, but doctors still rely on standard clinical monitoring.
Accelerated approval 1 article
Accelerated Approval is an FDA pathway that can permit earlier marketing authorization for drugs treating serious conditions based on a surrogate or intermediate clinical endpoint reasonably likely to predict clinical benefit. The pathway is designed for settings with unmet medical need and generally requires further evidence to verify benefit after approval. It differs from ordinary approval based directly on established clinical outcomes, and authorization can be subject to withdrawal if required confirmatory evidence does not verify the expected benefit.