Tasigna (nilotinib) vs Xospata (gilteritinib)

Tasigna (nilotinib) and Xospata (gilteritinib) are both oral medications used to treat certain types of leukemia, but they target different genetic mutations and stages of the disease. Tasigna is specifically approved for the treatment of chronic phase and accelerated phase Philadelphia chromosome-positive chronic myelogenous leukemia (CML) in adults who are newly diagnosed or who are resistant or intolerant to prior therapy, including imatinib. In contrast, Xospata is indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. For someone deciding which medicine is right for them, the choice would depend on the specific type and genetic profile of their leukemia, as well as their previous treatments and overall health status. It is essential to consult with a healthcare professional who can provide a personalized recommendation based on diagnostic tests and individual health considerations.

Difference between Tasigna and Xospata

Metric	Tasigna (nilotinib)	Xospata (gilteritinib)
Generic name	Nilotinib	Gilteritinib
Indications	Chronic myeloid leukemia (CML) with Philadelphia chromosome	Acute myeloid leukemia (AML) with FLT3 mutation
Mechanism of action	Tyrosine kinase inhibitor	Tyrosine kinase inhibitor
Brand names	Tasigna	Xospata
Administrative route	Oral	Oral
Side effects	Headache, fatigue, nausea, rash, pruritus, constipation, alopecia, myalgia	Fatigue, fever, musculoskeletal pain, nausea, edema, dyspnea, cough, rash, diarrhea
Contraindications	Long QT syndrome, hypokalemia, hypomagnesemia, liver impairment	QT prolongation, hypersensitivity to gilteritinib
Drug class	Tyrosine kinase inhibitor	Tyrosine kinase inhibitor
Manufacturer	Novartis	Astellas Pharma

Efficacy

Tasigna (Nilotinib) Efficacy in Chronic Myeloid Leukemia (CML)

Tasigna, also known by its generic name nilotinib, is a medication specifically indicated for the treatment of chronic myeloid leukemia (CML) in adult and pediatric patients. Its efficacy has been demonstrated in several clinical trials, particularly in patients with Philadelphia chromosome-positive CML in the chronic phase. Nilotinib is a tyrosine kinase inhibitor that targets the BCR-ABL kinase, which is produced by the Philadelphia chromosome abnormality in CML cells. By inhibiting this kinase, Tasigna effectively reduces the proliferation of leukemic cells.

Clinical studies have shown that patients treated with nilotinib often achieve a complete cytogenetic response (CCyR) and a major molecular response (MMR), which are indicators of the effectiveness of the drug in reducing the number of leukemic cells. The rates of achieving CCyR and MMR with nilotinib are higher compared to alternative treatments such as imatinib, another tyrosine kinase inhibitor. Furthermore, long-term follow-up studies indicate that the responses are durable, with many patients maintaining their response over time.

Xospata (Gilteritinib) Efficacy in Acute Myeloid Leukemia (AML)

Xospata, with the generic name gilteritinib, is an oral medication approved for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. Gilteritinib is a FLT3/AXL inhibitor, which works by blocking the growth of leukemic cells that have the FLT3 mutation. The presence of FLT3 mutations in AML is associated with a poor prognosis, and gilteritinib provides a targeted therapy option for this specific patient population.

The efficacy of Xospata was evaluated in clinical trials where it demonstrated an ability to induce complete remission (CR) or complete remission with partial hematologic recovery (CRh) in a significant proportion of patients. Additionally, gilteritinib has shown a survival benefit compared to chemotherapy in patients with relapsed or refractory AML with a FLT3 mutation. The drug has been a significant advancement in the treatment of AML, offering hope for improved outcomes in a disease that is often challenging to treat.

Regulatory Agency Approvals

Tasigna

European Medical Agency (EMA), European Union
Food and Drug Administration (FDA), USA
Health Canada
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Therapeutic Goods Administration (TGA), Australia
Medsafe (NZ)

Xospata

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

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