Tag

Imetelstat

All articles tagged with #imetelstat

health-pharmaceuticals1 year ago•1 min saved

"Geron's Imetelstat Receives FDA Advisers' Backing for Blood Disorder Treatment"

FDA advisers backed Geron's blood disorder drug, imetelstat, for treating transfusion-dependent anemia in patients with myelodysplastic syndromes, despite concerns about risks and toxicities. The panel voted 12-to-2 in favor of the drug's benefits, with discussions focusing on the high rate of cytopenias in patients tested with the drug. If approved, imetelstat will compete with Bristol Myers Squibb's Reblozyl and is projected to generate $933 million in sales by 2029. The FDA is expected to make a decision on the drug by June 16.

via Yahoo Finance|

#blood-disorder #fda #geron

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