Onureg (azacitidine) vs Xospata (gilteritinib)

Onureg (azacitidine) vs Xospata (gilteritinib)

Onureg (azacitidine) is a hypomethylating agent commonly used for the treatment of adults with newly-diagnosed acute myeloid leukemia (AML) who are not eligible for intensive chemotherapy, with a mechanism that involves the reactivation of silenced genes that suppress tumor growth. Xospata (gilteritinib), on the other hand, is a targeted therapy specifically indicated for adult patients with AML who have a FLT3 mutation, as detected by an FDA-approved test, and works by inhibiting the growth of AML cells with this mutation. The choice between Onureg and Xospata would depend on the specific characteristics of the AML, including the patient's overall health, eligibility for intensive chemotherapy, and the presence of a FLT3 mutation, thus necessitating a thorough discussion with a healthcare provider to determine the most appropriate treatment option.

Difference between Onureg and Xospata

Metric Onureg (azacitidine) Xospata (gilteritinib)
Generic name Azacitidine Gilteritinib
Indications Acute myeloid leukemia (AML) in adults who are in remission Relapsed or refractory AML with an FLT3 mutation
Mechanism of action Hypomethylating agent that incorporates into DNA and RNA Tyrosine kinase inhibitor that targets FLT3/AXL
Brand names Onureg Xospata
Administrative route Oral Oral
Side effects Nausea, vomiting, diarrhea, constipation, hematological abnormalities Fatigue, elevated liver enzymes, musculoskeletal pain, fever, rash
Contraindications Advanced malignant hepatic tumors, hypersensitivity to azacitidine or mannitol Hypersensitivity to gilteritinib
Drug class Nucleoside metabolic inhibitor Tyrosine kinase inhibitor
Manufacturer Bristol Myers Squibb Astellas Pharma

Efficacy

Onureg (Azacitidine) Efficacy in Leukemia

Onureg, known generically as azacitidine, is a hypomethylating agent that has shown efficacy in the treatment of acute myeloid leukemia (AML), specifically in patients with a particular subset of this condition. It is approved for the continued treatment of adult patients with AML who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy. Clinical trials have demonstrated that maintenance therapy with Onureg can significantly improve overall survival in these patients compared to placebo. The efficacy of Onureg in this context provides a valuable option for patients who are in remission but are not candidates for stem cell transplant or further intensive chemotherapy.

Xospata (Gilteritinib) Efficacy in Leukemia

Xospata, or gilteritinib, is a targeted therapy specifically designed for the treatment of AML with a FLT3 mutation, which is present in approximately 30% of AML patients. This mutation is associated with a particularly aggressive form of the disease and a poorer prognosis. Xospata has been shown to be effective in inducing remission in patients with relapsed or refractory AML with a FLT3 mutation. In clinical studies, gilteritinib has not only demonstrated the ability to achieve remission but has also shown an improvement in overall survival rates compared to chemotherapy. This efficacy highlights the importance of FLT3 mutation testing in AML patients to identify those who may benefit from Xospata treatment.

Comparative Efficacy in Leukemia Treatment

When comparing the efficacy of Onureg and Xospata in the treatment of leukemia, it is important to note that they are used in different settings and for different subsets of AML patients. Onureg is used as a maintenance therapy for patients in remission who are not candidates for further intensive treatment, while Xospata is used for patients with relapsed or refractory AML who have a specific genetic mutation. Both medications represent advancements in the personalized treatment of AML, addressing the needs of patients based on their disease status and genetic characteristics.

Conclusion on Efficacy

In conclusion, both Onureg and Xospata have shown significant efficacy in the treatment of AML, albeit in distinct patient populations and stages of the disease. Onureg's role in extending survival in the maintenance setting and Xospata's effectiveness in targeting FLT3-mutated AML offer hope for improved outcomes in this challenging hematologic malignancy. The use of these medications reflects the growing trend towards personalized medicine in oncology, where treatments are tailored to the genetic and molecular profiles of individual patients' cancers.

Regulatory Agency Approvals

Onureg
  • Food and Drug Administration (FDA), USA
Xospata
  • European Medical Agency (EMA), European Union
  • Food and Drug Administration (FDA), USA
  • Health Canada
  • Therapeutic Goods Administration (TGA), Australia

Access Onureg or Xospata today

If Onureg or Xospata are not approved or available in your country (e.g. due to supply issues), you can access them via Everyone.org.

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