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Blood Cancer Expert Dr. Mikkael Sekeres Endorses FDA Approval of New Drug, Imetelstat
Mar 16, 2024, 15:53

Blood Cancer Expert Dr. Mikkael Sekeres Endorses FDA Approval of New Drug, Imetelstat

Dr. Mikkael Sekeres is an expert in blood cancers at Sylvester Comprehensive Cancer Center – University of Miami Health System. He served as chair of the Oncologic Drugs Advisory Committee (ODAC) for the trial that led to imetelstat vote of support at the FDA today. Imetelstat, also known as RYTELO, is telomerase inhibitor for the treatment of transfusion-dependent anemia in patients with lower risk myelodysplastic syndromes (MDS). It will be used for the treatment of certain adult patients with low- to intermediate-1 risk MDS who have not responded to, or have lost response to, or are ineligible for erythropoietin stimulating agents (ESA) used to aid blood transfusions.

“I believe the benefits associated with the drug justify the risks. The benefits are real. When you have 40% of the patients who previously depended on red blood cell transfusions who no longer need transfusions, and this outcome lasts for an average of one year, I think that’s a significant benefit,” Sekeres said.

He added:

  • Some 20,000 Americans are diagnosed with MDS annually.
  • Anemia typically affects people 70 years or older.
  • No treatment options are available for anemia after ESA’s lose their effectiveness.

Dr. Sekeres is chief of the Division of Hematology at Sylvester and his specialty focuses on leukemia and myeloid disorders. He has served on the editorial boards for several medical journals and chairs scientific advisory boards for patient advocacy groups and research funding agencies. He has been the primary study investigator on dozens of phase I, II and III clinical trials, and has authored over 450 scientific articles. He is also an expert on CAR-T cell therapy causing t-cell malignancies issues, topic of ODAC’s meeting on Friday.