Difference between revisions of "Gemtuzumab ozogamicin (Mylotarg)"
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==General information== | ==General information== | ||
| − | Class/mechanism: Antibody-cytotoxic agent conjugate. Gemtuzumab ozogamicin is comprised of a recombinant humanized IgG4 kappa antibody against CD33--an adhesion protein expressed on the surface of leukemic blasts and immature normal cells of myelomonocytic lineage, but not on normal hematopoietic stem cells--conjugated with a cytotoxic agent, calicheamicin. The antibody-cytotoxic agent is internalized after binding, and the calicheamicin derivative binds to DNA in the minor groove, causing DNA double strand breaks and cell death.<ref name="insert">[http://labeling.pfizer.com/showlabeling.aspx?id=119 Gemtuzumab ozogamicin (Mylotarg) package insert]</ref><ref>[ | + | Class/mechanism: Antibody-cytotoxic agent conjugate. Gemtuzumab ozogamicin is comprised of a recombinant humanized IgG4 kappa antibody against CD33--an adhesion protein expressed on the surface of leukemic blasts and immature normal cells of myelomonocytic lineage, but not on normal hematopoietic stem cells--conjugated with a cytotoxic agent, calicheamicin. The antibody-cytotoxic agent is internalized after binding, and the calicheamicin derivative binds to DNA in the minor groove, causing DNA double strand breaks and cell death.<ref name="insert">[http://labeling.pfizer.com/showlabeling.aspx?id=119 Gemtuzumab ozogamicin (Mylotarg) package insert]</ref><ref>[https://hemonc.org/docs/packageinsert/gemtuzumabozogamicin.pdf Gemtuzumab ozogamicin (Mylotarg) package insert (locally hosted backup)]</ref> |
<br>Route: IV | <br>Route: IV | ||
<br>Extravasation: no information | <br>Extravasation: no information | ||
| − | For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias | + | For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias or the prescribing information.<ref name="insert"></ref> |
| + | ==Diseases for which it is established== | ||
| + | *[[Acute myeloid leukemia]] | ||
==Diseases for which it is used== | ==Diseases for which it is used== | ||
| − | |||
*[[Acute promyelocytic leukemia]] | *[[Acute promyelocytic leukemia]] | ||
| Line 15: | Line 16: | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | *2000-05-17: Granted accelerated approval for the treatment of patients with [[Biomarkers#CD33|CD33]] [[Biomarkers#Expression|positive]] [[Acute myeloid leukemia | acute myeloid leukemia]] in first relapse who are 60 years of age or older and who are not considered candidates for cytotoxic chemotherapy. ''(Based on | + | *2000-05-17: Granted accelerated approval for the treatment of patients with [[Biomarkers#CD33|CD33]] [[Biomarkers#Expression|positive]] [[Acute myeloid leukemia | acute myeloid leukemia]] in first relapse who are 60 years of age or older and who are not considered candidates for cytotoxic chemotherapy. ''(Based on GO study 1, GO study 2, and GO study 3)'' |
| − | **2011-11-28: | + | **2011-11-28: Accelerated approval for [[acute myeloid leukemia]] withdrawn. ''(Based on SWOG S0106)'' |
*2017-09-01: New approval for the treatment of newly-diagnosed [[Biomarkers#CD33|CD33]]-[[Biomarkers#Expression|positive]] [[Acute myeloid leukemia |acute myeloid leukemia (AML)]] in adults. Gemtuzumab ozogamicin may be used in combination with daunorubicin and cytarabine for adults with newly-diagnosed AML. ''(Based on ALFA-0701 and EORTC/GIMEMA AML-19)'' | *2017-09-01: New approval for the treatment of newly-diagnosed [[Biomarkers#CD33|CD33]]-[[Biomarkers#Expression|positive]] [[Acute myeloid leukemia |acute myeloid leukemia (AML)]] in adults. Gemtuzumab ozogamicin may be used in combination with daunorubicin and cytarabine for adults with newly-diagnosed AML. ''(Based on ALFA-0701 and EORTC/GIMEMA AML-19)'' | ||
*2017-09-01: New approval for treatment of relapsed or refractory [[Biomarkers#CD33|CD33]]-[[Biomarkers#Expression|positive]] [[Acute myeloid leukemia |AML]] in adults and in pediatric patients 2 years and older. ''(Based on MyloFrance-1)'' | *2017-09-01: New approval for treatment of relapsed or refractory [[Biomarkers#CD33|CD33]]-[[Biomarkers#Expression|positive]] [[Acute myeloid leukemia |AML]] in adults and in pediatric patients 2 years and older. ''(Based on MyloFrance-1)'' | ||
*2020-06-16: Approved for newly-diagnosed [[Biomarkers#CD33|CD33]]-[[Biomarkers#Expression|positive]] [[Acute myeloid leukemia|acute myeloid leukemia (AML)]] to include pediatric patients 1 month and older. ''(Approval expanded to pediatric patients 1 month and older; based on COG AAML0531)'' | *2020-06-16: Approved for newly-diagnosed [[Biomarkers#CD33|CD33]]-[[Biomarkers#Expression|positive]] [[Acute myeloid leukemia|acute myeloid leukemia (AML)]] to include pediatric patients 1 month and older. ''(Approval expanded to pediatric patients 1 month and older; based on COG AAML0531)'' | ||
| + | |||
==History of changes in EMA indication== | ==History of changes in EMA indication== | ||
*2018-04-19: Marketing authorisation (unclear if this is initial or re-authorisation) | *2018-04-19: Marketing authorisation (unclear if this is initial or re-authorisation) | ||
| + | *Uncertain date: Mylotarg is indicated for combination therapy with daunorubicin (DNR) and cytarabine (AraC) for the treatment of patients age 15 years and above with previously untreated, de novo CD33-positive [[Acute myeloid leukemia|acute myeloid leukaemia (AML)]], except acute promyelocytic leukaemia (APL). ''(Based on ALFA-0701)'' | ||
| + | |||
==History of changes in Health Canada indication== | ==History of changes in Health Canada indication== | ||
*2019-11-28: Initial notice of compliance | *2019-11-28: Initial notice of compliance | ||
Latest revision as of 01:06, 29 June 2024
General information
Class/mechanism: Antibody-cytotoxic agent conjugate. Gemtuzumab ozogamicin is comprised of a recombinant humanized IgG4 kappa antibody against CD33--an adhesion protein expressed on the surface of leukemic blasts and immature normal cells of myelomonocytic lineage, but not on normal hematopoietic stem cells--conjugated with a cytotoxic agent, calicheamicin. The antibody-cytotoxic agent is internalized after binding, and the calicheamicin derivative binds to DNA in the minor groove, causing DNA double strand breaks and cell death.[1][2]
Route: IV
Extravasation: no information
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias or the prescribing information.[1]
Diseases for which it is established
Diseases for which it is used
Patient drug information
- Gemtuzumab ozogamicin (Mylotarg) package insert[1]
- Gemtuzumab ozogamicin (Mylotarg) patient drug information (Chemocare)[3]
History of changes in FDA indication
- 2000-05-17: Granted accelerated approval for the treatment of patients with CD33 positive acute myeloid leukemia in first relapse who are 60 years of age or older and who are not considered candidates for cytotoxic chemotherapy. (Based on GO study 1, GO study 2, and GO study 3)
- 2011-11-28: Accelerated approval for acute myeloid leukemia withdrawn. (Based on SWOG S0106)
- 2017-09-01: New approval for the treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults. Gemtuzumab ozogamicin may be used in combination with daunorubicin and cytarabine for adults with newly-diagnosed AML. (Based on ALFA-0701 and EORTC/GIMEMA AML-19)
- 2017-09-01: New approval for treatment of relapsed or refractory CD33-positive AML in adults and in pediatric patients 2 years and older. (Based on MyloFrance-1)
- 2020-06-16: Approved for newly-diagnosed CD33-positive acute myeloid leukemia (AML) to include pediatric patients 1 month and older. (Approval expanded to pediatric patients 1 month and older; based on COG AAML0531)
History of changes in EMA indication
- 2018-04-19: Marketing authorisation (unclear if this is initial or re-authorisation)
- Uncertain date: Mylotarg is indicated for combination therapy with daunorubicin (DNR) and cytarabine (AraC) for the treatment of patients age 15 years and above with previously untreated, de novo CD33-positive acute myeloid leukaemia (AML), except acute promyelocytic leukaemia (APL). (Based on ALFA-0701)
History of changes in Health Canada indication
- 2019-11-28: Initial notice of compliance
History of changes in PMDA indication
- 2005-07-25: Initial approval for the treatment of relapsing or intractable CD33 positive acute myeloid leukemia.
Also known as
- Brand name: Mylotarg
References
Categories:
- Drugs
- Intravenous medications
- Protein expression-specific medications
- Anti-CD33 antibody-drug conjugates
- Enediyne antibiotic
- Acute myeloid leukemia medications
- Acute promyelocytic leukemia medications
- FDA approved in 2000
- FDA withdrawn in 2011
- FDA approved in 2017
- EMA approved in 2018
- Health Canada approved in 2019
- PMDA approved in 2005