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Kenneth C. Anderson, MD, discusses the recent ODAC decisions for ide-cel and cilta-cel, highlighting clinical trial data supporting the indications. ....
The FDA’s ODAC voted that data support the use of minimal residual disease as an end point to support accelerated approval of treatments in multiple myeloma. ....
By a unanimous 12-0 vote, the U.S. FDA’s Oncologic Drugs Advisory Committee concluded that new evidence support the use of minimal residual disease (MRD) as an accelerated approval endpoint in multiple myeloma (MM) clinical trials. ....