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Oncologic Drugs Advisory Committee

All articles tagged with #oncologic drugs advisory committee

healthcare1 year ago•8 min saved

FDA Advisory Committee Unanimously Approves MRD as Endpoint for Myeloma Trials

The FDA's Oncologic Drugs Advisory Committee voted 12 to 0 in favor of using minimal residual disease (MRD) as an accelerated approval endpoint in multiple myeloma clinical trials. This decision could potentially lead to earlier access to effective treatments for patients and the possibility of stopping therapy based on MRD. The use of MRD as an endpoint in different myeloma disease settings and the acceptability of time points for MRD assessment were also discussed during the meeting.

via Targeted Oncology|

#clinical-trials #fda #healthcare

health1 year ago•8 min saved

FDA Advisory Committee Votes in Favor of Geron's Imetelstat for Anemia in Lower-Risk MDS

The FDA Oncologic Drugs Advisory Committee voted 12 to 2 in favor of the clinical benefit/risk profile of imetelstat for the treatment of transfusion-dependent anemia in adult patients with low-to-intermediate-1 risk myelodysplastic syndromes (LR-MDS). Geron Corporation's imetelstat, a telomerase inhibitor, demonstrated positive results in the IMerge Phase 3 clinical trial, showing significant improvement in red blood cell transfusion independence and hemoglobin levels. The FDA has set a PDUFA target action date of June 16, 2024 for imetelstat's New Drug Application, and Geron plans to launch imetelstat in the U.S. upon potential FDA approval.

via Yahoo Finance|

#fda #geron-corporation #health