International Myeloma Foundation Celebrates ODAC Meeting Outcome on Minimal Residual Disease (MRD) Testing as an Early Endpoint for the Accelerated Approval of Myeloma Drugs in Clinical Trials: A Huge Win for the Global Myeloma Community
This means that the FDA may approve multiple myeloma drugs in the development pipeline much sooner.
- This means that the FDA may approve multiple myeloma drugs in the development pipeline much sooner.
- To date, many myeloma drug approvals take 9-12 years and must demonstrate a progression-free survival of 5-8 years.
- With MRD testing as an early endpoint in clinical trials, researchers can reliably predict progression-free survival and overall survival for multiple myeloma patients, making it a precise early endpoint.
- He cited the IMF’s collaboration with the i2TEAMM (or, the International Independent Team for Endpoint Approval in Multiple Myeloma).