ODAC Agrees with Faster Approval Route for Multiple Myeloma Drugs Free

The FDA’s Oncology Drug Advisory Committee (ODAC) unanimously recommended that the agency consider using minimal residual disease (MRD) as an acceptable endpoint in granting accelerated approval of therapies for multiple myeloma instead of overall response rate (ORR). With more than 90% of patients responding to a new drug, demonstrating its clinical superiority using progression-free survival (PFS) or overall survival (OS) as endpoint for full approval can take many years, whereas clinicians can start to see improvement in MRD within months. Studies have shown that MRD negativity correlates with clinical improvement using PFS and OS. The FDA usually—although not always—follows the recommendation of its advisory committee.