Difference between revisions of "Ivosidenib (Tibsovo)"
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==General information== | ==General information== | ||
| − | Class/mechanism: IDH1 inhibitor. Ivosidenib inhibits the mutant isocitrate dehydrogenase 1 (IDH1) enzyme at lower drug concentrations than wild-type IDH1. Inhibiting mutant IDH1 enzyme prevents formation of the oncometabolite 2-hydroxyglutarate (2HG) in leukemia cells, causes a reduction in IDH1-expressing tumor cells, and increases percentages of mature myeloid cells.<ref name="insert">[https://www. | + | Class/mechanism: IDH1 inhibitor. Ivosidenib inhibits the mutant isocitrate dehydrogenase 1 (IDH1) enzyme at lower drug concentrations than wild-type IDH1. Inhibiting mutant IDH1 enzyme prevents formation of the oncometabolite 2-hydroxyglutarate (2HG) in leukemia cells, causes a reduction in IDH1-expressing tumor cells, and increases percentages of mature myeloid cells.<ref name="insert">[https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211192s000lbl.pdf Ivosidenib (Tibsovo) package insert]</ref><ref>[[:File:Ivosidenib.pdf | Ivosidenib (Tibsovo) package insert (locally hosted backup)]]</ref><ref>[https://www.tibsovo.com/ Tibsovo manufacturer's website]</ref> |
| − | ==Diseases for which it is | + | ==Diseases for which it is established== |
*[[Acute_myeloid_leukemia,_IDH-mutated|IDH1-mutated AML]] | *[[Acute_myeloid_leukemia,_IDH-mutated|IDH1-mutated AML]] | ||
| + | *[[Myelodysplastic_syndrome,_IDH-mutated|IDH1-mutated MDS]] | ||
| + | *[[Cholangiocarcinoma]] | ||
==Patient drug information== | ==Patient drug information== | ||
| − | *[https://www. | + | *[https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211192s000lbl.pdf Ivosidenib (Tibsovo) package insert]<ref name="insert"></ref> |
| − | *[ | + | *[https://chemocare.com/druginfo/ivosidenib.aspx Ivosidenib (Tibsovo) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/ivosidenib.aspx Ivosidenib (Tibsovo) patient drug information (Chemocare)]</ref> |
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * | + | ===[[Acute myeloid leukemia]]=== |
| − | * | + | * 2018-07-20: Granted approval for adult patients with relapsed or refractory [[Acute_myeloid_leukemia|acute myeloid leukemia (AML)]] with a susceptible [[Biomarkers#IDH1|IDH1]] [[Biomarkers#Alterations|mutation]] as detected by an FDA-approved test. ''(Based on AG120-C-001 r/r)'' |
| + | * 2019-05-02: [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ivosidenib-first-line-treatment-aml-idh1-mutation FDA approval expanded] for newly-diagnosed [[Acute_myeloid_leukemia|acute myeloid leukemia (AML)]] with a susceptible [[Biomarkers#IDH1|IDH1]] [[Biomarkers#Alterations|mutation]], as detected by an FDA-approved test, in patients who are at least 75 years old or who have comorbidities that preclude the use of intensive induction chemotherapy. ''(approval expanded to first-line setting with limitations; based on AG120-C-001 untreated)'' | ||
| + | * 2022-05-25: Approved in combination with azacitidine for newly diagnosed [[Acute_myeloid_leukemia|acute myeloid leukemia (AML)]] with a susceptible [[Biomarkers#IDH1|IDH1]] [[Biomarkers#Alterations|mutation]], as detected by an FDA-approved test in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. ''(Based on AGILE)'' | ||
| + | ===[[Cholangiocarcinoma]]=== | ||
| + | * 2021-08-25: Approved for adult patients with previously treated, locally advanced or metastatic [[cholangiocarcinoma]] with an [[Biomarkers#IDH1|isocitrate dehydrogenase-1 (IDH1)]] [[Biomarkers#Alterations|mutation]]. ''(Based on ClarIDHy)'' | ||
| + | ===[[Myelodysplastic syndrome|Myelodysplastic syndrome (MDS)]]=== | ||
| + | *2023-10-24: Approved for adult patients with relapsed or refractory [[Myelodysplastic syndrome|myelodysplastic syndromes (MDS)]] with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation. ''(Based on AG120-C-001 r/r)'' | ||
| + | |||
| + | ==History of changes in EMA indication== | ||
| + | *2023-05-04: Tibsovo in combination with azacitidine is indicated for the treatment of adult patients with newly diagnosed [[Acute_myeloid_leukemia|acute myeloid leukaemia (AML)]] with an isocitrate dehydrogenase-1 (IDH1) R132 mutation who are not eligible to receive standard induction chemotherapy. | ||
| + | *2023-05-04: Tibsovo monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic [[cholangiocarcinoma]] with an IDH1 R132 mutation who were previously treated by at least one prior line of systemic therapy. | ||
==Also known as== | ==Also known as== | ||
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[[Category:Drugs]] | [[Category:Drugs]] | ||
[[Category:Oral medications]] | [[Category:Oral medications]] | ||
| + | [[Category:Mutation-specific medications]] | ||
[[Category:IDH1 inhibitors]] | [[Category:IDH1 inhibitors]] | ||
[[Category:Acute myeloid leukemia medications]] | [[Category:Acute myeloid leukemia medications]] | ||
| + | [[Category:Cholangiocarcinoma medications]] | ||
| + | [[Category:Myelodysplastic syndrome medications]] | ||
[[Category:FDA approved in 2018]] | [[Category:FDA approved in 2018]] | ||
| + | [[Category:EMA approved in 2023]] | ||
Latest revision as of 13:55, 9 February 2024
General information
Class/mechanism: IDH1 inhibitor. Ivosidenib inhibits the mutant isocitrate dehydrogenase 1 (IDH1) enzyme at lower drug concentrations than wild-type IDH1. Inhibiting mutant IDH1 enzyme prevents formation of the oncometabolite 2-hydroxyglutarate (2HG) in leukemia cells, causes a reduction in IDH1-expressing tumor cells, and increases percentages of mature myeloid cells.[1][2][3]
Diseases for which it is established
Patient drug information
History of changes in FDA indication
Acute myeloid leukemia
- 2018-07-20: Granted approval for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test. (Based on AG120-C-001 r/r)
- 2019-05-02: FDA approval expanded for newly-diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved test, in patients who are at least 75 years old or who have comorbidities that preclude the use of intensive induction chemotherapy. (approval expanded to first-line setting with limitations; based on AG120-C-001 untreated)
- 2022-05-25: Approved in combination with azacitidine for newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved test in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. (Based on AGILE)
Cholangiocarcinoma
- 2021-08-25: Approved for adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 (IDH1) mutation. (Based on ClarIDHy)
Myelodysplastic syndrome (MDS)
- 2023-10-24: Approved for adult patients with relapsed or refractory myelodysplastic syndromes (MDS) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation. (Based on AG120-C-001 r/r)
History of changes in EMA indication
- 2023-05-04: Tibsovo in combination with azacitidine is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) with an isocitrate dehydrogenase-1 (IDH1) R132 mutation who are not eligible to receive standard induction chemotherapy.
- 2023-05-04: Tibsovo monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation who were previously treated by at least one prior line of systemic therapy.
Also known as
- Code name: AG-120
- Brand name: Tibsovo