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Patient Fitness in AML
The content of this website has been produced in line with the MYLOTARG®▼ (gemtuzumab ozogamicin) Summary of Product Characteristics for Great Britain and Northern Ireland. For MYLOTARG®▼ (gemtuzumab ozogamicin) and cytarabine Prescribing Information Click here. Adverse event reporting information can be found at the bottom of the page.
Daunorubicin (60 mg/m2 IV, Days 1–3) + cytarabine (100–200 mg/m2/day continuous IV infusion, Days 1–7) + MYLOTARG (3 mg/m2 [max. one 5 mg vial] IV, Days 1, 4 and 7)Λ, Re-induction (if not in CR/CRh/CRi) may be with daunorubicin 60 mg/m2 IV days 1–2 and cytarabine 1000 mg/m2 IV (500–1000 mg/m2 if ≥60 years old) over 3 hours q12h Days 1–3 without MYLOTARG.
The MYLOTARG SmPC states that for induction, the recommended dose of MYLOTARG is 3 mg/m2/dose (up to a maximum of one 5 mg vial) infused over a 2-hour period on Days 1, 4, and 7 in combination with daunorubicin 60 mg/m2/day infused over 30 minutes on Day 1 to Day 3, and cytarabine 200 mg/m2/day by continuous infusion on Day 1 to Day 7. If a second induction is required, MYLOTARG should not be administered during second induction therapy. Only daunorubicin and cytarabine should be administered during the second induction cycle, at the following recommended dosing: daunorubicin 35 mg/m2/day on Days 1 and 2, and cytarabine 1 g/m2 every 12 hours, on Days 1–32.
2–4 cycles of intermediate-dose cytarabine
(1000–1500 mg/m2 IV over 3 hours q12h on Days 1–3).
MYLOTARG 3 mg/m2 (max. one 5 mg vial) may be added on Day 1 (in up to 2 cycles)∧ß
2–4 cycles of intermediate-dose cytarabine
(500–1000 mg/m2 IV over 3 hours q12h on Days 1–3).
MYLOTARG 3 mg/m2 (max. one 5 mg vial) may
be added on Day 1 (in up to 2 cycles)∧ß
The MYLOTARG SmPC states that for consolidation, up to 2 consolidation courses of IV daunorubicin (60 mg/m2 for 1 day [first course] or 2 days [second course]) in combination with IV cytarabine (1 g/m2 per 12 hours, infused over 2 hours on Day 1 to Day 4) with IV MYLOTARG (3 mg/m2/dose infused over 2 hours up to a maximum dose of one 5 mg vial on Day 1) are recommended2.
For more information on treatment recommendations for AML with FLT3 mutation, non-FLT3 mutant AML and treatment-related AML, please refer to the ELN 2022 guidelines1
Patient cytogenetics are determined through FISH and RT-PCR, and are used to stratify patients into three risk categories: favourable, intermediate and adverse.
Watch Professor Robert Hills discuss the key clinical data from the pivotal ALFA study.
Watch Dr. Sreetharan Munisamy discuss the current treatment landscape for de novo AML in Video 1 of the Key Topics in the Management of de novo AML video series. Click the link below to explore the rest of the on-demand series.
AML, acute myeloid leukaemia; CD, cluster of differentiation; CR, complete remission; CRh, complete remission with partial haematologic recovery; CRi, complete remission with incomplete haematologic recovery; DGH, District General Hospital; ELN, European LeukemiaNET; FISH, flourescence in-situ hybridisation; FLT3, fms-like tyrosine kinase 3; GO, gemtuzumab ozogamicin; HCT, hematopoietic cell transplantation; IV, intravenous; MRD, minimal residual disease; NICE, National Institute for Health and Care Excellence; q12h, every 12 hours; RT-PCR, revserse-transcriptase polymerase chain reaction; SMC, Scottish Medicines Consortium
∧ In up to 2 cycles; ß Consider omitting MYLOTARG if allogeneic HCT is planned to reduce the risk of veno-occlusive disease.
*Mainly based on results observed in intensively-treated patients. Initial risk assignment may change during the treatment course based on the results from analyses of measurable residual disease; †Concurrent KIT and/or FLT3 gene mutation does not alter risk categorisation; ‡AML with NPM1 mutation and adverse-risk cytogenetic abnormalities are categorised as adverse-risk; §Only in-frame mutations affecting the basic leucine zipper (bZIP) region of CEBPA, irrespective of whether they occur as monoallelic or biallelic mutations, have been associated with favorable outcome; |The presence of t(9;11 (p21.3;q23.3) takes precedence over rare, concurrent adverse risk gene mutations; ¶Excluding KMT2A partial tandem duplication (PTD); #Complex karyotype: ≥3 unrelated chromosome abnormalities in the absence of other class-defining recurring genetic abnormalities; excludes hyperdiploid karyotypes with three or more trisomies (or polysomies) without structural abnormalities; **Monosomal karyotype: presence of two or more distinct monosomies (excluding loss of X or Y), or one single autosomal monosomy in combination with at least one structural chromosome abnormality (excluding core-binding factor AML); ††For the time being, these markers should not be used as an adverse prognostic marker if they co-occur with favorable-risk AML subtypes; ‡‡TP53 mutation at a variant allele fraction of at least 10%, irrespective of the TP53 allelic status (mono- or biallelic mutation): TP53 mutations are significantly associated with AML with complex and monosomal karyotype
References
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PP-UNP-GBR-7812. January 2024