Difference between revisions of "Gemtuzumab ozogamicin (Mylotarg)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | *5/17/2000: Granted FDA 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. | + | *5/17/2000: Granted FDA 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 Sievers et al. 2001 and others)'' |
*10/15/2010: '''Withdrawn from US market'''<ref>[http://www.pfizer.com/files/products/mylotarg_hcp_letter.pdf Pfizer letter to healthcare providers (6/21/2010)]</ref> ''(Based on SWOG S0106)'' | *10/15/2010: '''Withdrawn from US market'''<ref>[http://www.pfizer.com/files/products/mylotarg_hcp_letter.pdf Pfizer letter to healthcare providers (6/21/2010)]</ref> ''(Based on SWOG S0106)'' | ||
*9/1/2017: New FDA 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)'' | *9/1/2017: New FDA 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)'' | ||
Revision as of 12:26, 7 June 2021
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 such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]
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
- 5/17/2000: Granted FDA 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 Sievers et al. 2001 and others)
- 10/15/2010: Withdrawn from US market[4] (Based on SWOG S0106)
- 9/1/2017: New FDA 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)
- 9/1/2017: New FDA approval for treatment of relapsed or refractory CD33-positive AML in adults and in pediatric patients 2 years and older. (Based on MyloFrance-1)
- 6/16/2020: 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)
Also known as
- Brand name: Mylotarg