Xospata

Gilteritinib

• Brand(s): Xospata
• Dosage Form/Strength: 40 mg tablet
• Effective date: December 1, 2021

For the treatment of adult patients diagnosed with relapsed or refractory FMS-like tyrosine kinase 3 (FLT3)-mutated acute myeloid leukemia (AML) who meet the following criteria:

1. Patient has relapsed or is considered to be refractory to a prior chemotherapy regimen used for AML.

2. FLT3 mutation with either a FLT3-ITD, FLT3-TKD/D835 or FLT3-TKD/I836 is confirmed by an approved test taken after relapse on a chemotherapy regimen; AND

3. Patient has good performance status (e.g., ECOG less than or equal to 2).

Exclusion criteria: (Requests meeting ANY of the following criteria will not be funded.)

• Patients with therapy-related AML.
• Patients who have had a prior relapse while being treated with gilteritinib or another tyrosine kinase inhibitor (TKI) specific to FLT3-mutated AML in the relapsed or refractory AML setting.
• Gilteritinib is not funded for induction or consolidation therapy for AML (i.e. not funded for earlier lines of treatment prior to refractory or relapsed disease).

Renewal Criteria:
Treatment to continue until disease progression or until unacceptable toxicity occurs. At the time of renewal please include a brief summary of the clinical benefit that has been observed (e.g., partial or complete remission, reduction in transfusions etc.)

Notes:

1. A delay in clinical response can occur and it is recommended that treatment with gilteritinib be continued for a minimum of six months (i.e., in the absence of disease progression or unacceptable toxicity).

2. Patients may be considered to have refractory AML after progression on a minimum of one cycle of induction chemotherapy in accordance with the prescriber’s clinical assessment.

3. Dose escalations to achieve complete remission will be permitted but dose should not be escalated after achieving complete remission.

4. Patients who receive gilteritinib in relapsed or refractory AML who progress to a hematopoietic stem cell transplant will be able to continue on gilteritinib as maintenance until disease progression.

For a time-limited period, patients currently receiving salvage chemotherapy for relapsed or refractory AML and patients in second hematologic relapse or later may be considered for funding on a case-by-case basis if they did not relapse on a prior TKI in the relapse/refractory setting if they have FLT3 mutated AML.

Recommended dose: 120mg once daily

Duration of approval of initial requests: 7 months

Duration of approval or renewals: 1 year

EAP Drug Request Form:

Standard Form for EAP Drug Requests