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Trisenox Receives Orphan Drug Designation for Treating Chronic Myeloid and Acute Myelocytic Leukemias

Strategic Insights

— 1 min read

Cell Therapeutics, Inc.'s novel cancer drug treatment, Trisenox, has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of both chronic myeloid (CML) and acute myelocytic (AML) leukemias. This designation, combined with other recent recognitions, brings the total number of orphan drug designations for Trisenox to five. The company is conducting clinical trials to study the effectiveness of Trisenox as a single agent and in combination with Gleevec for CML. Additionally, the U.S. National Cancer Institute (NCI) is sponsoring clinical trials for AML in Phase II.

Key Takeaways:

  • Trisenox, a novel cancer drug treatment, has been granted orphan drug designation by the FDA for the treatment of CML and AML, bringing the total number of orphan designations to five.
  • The company is conducting clinical trials to study the effectiveness of Trisenox as a single agent and in combination with Gleevec for CML.
  • The U.S. National Cancer Institute (NCI) is sponsoring several clinical trials for AML in Phase II.
  • According to the Leukemia and Lymphoma Society, nearly 15,000 new patients are diagnosed with CML or AML every year in the United States.
  • CML is a moderately progressive form of leukemia characterized by the presence of large numbers of granulocytes in the blood, while AML is a progressive leukemia that starts by the malignant transformation of an immature cell in the bone marrow.
  • Orphan drug designation is granted to applicants when the prevalence of the disease occurs in fewer than 200,000 patients in the United States.
  • Carolyn Paradise, MD, CTI, described the significance of these new designations, stating that they provide opportunities to develop drugs for patients with rare diseases.

Statistics:

  • 5: The total number of orphan drug designations for Trisenox.
  • 15,000: The number of new patients diagnosed with CML or AML every year in the United States.
  • 200,000: The patient prevalence threshold for orphan drug designation.
  • 2: The number of leukemias designated for Trisenox, including CML and AML.

Sources:

  • Blood Weekly editors from staff and other reports

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