Difference between revisions of "Decitabine and cedazuridine (Inqovi)"
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(Created page with "==Mechanism of action== From the [https://www.cancer.gov/publications/dictionaries/cancer-drug/def/cda-inhibitor-e7727-decitabine-combination-agent-astx727 NCI Drug Dictionary...") |
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==Mechanism of action== | ==Mechanism of action== | ||
| − | From the [https://www.cancer.gov/publications/dictionaries/cancer-drug/def/cda-inhibitor-e7727-decitabine-combination-agent-astx727 NCI Drug Dictionary | + | From the [https://www.cancer.gov/publications/dictionaries/cancer-drug/def/cda-inhibitor-e7727-decitabine-combination-agent-astx727 NCI Drug Dictionary]: An orally available combination agent containing the cytidine deaminase (CDA) inhibitor E7727 and the cytidine antimetabolite decitabine, with potential antineoplastic activity. Upon oral administration of decitabine and cedazuridine, the CDA inhibitor E7727 binds to and inhibits CDA, an enzyme primarily found in the gastrointestinal (GI) tract and liver that catalyzes the deamination of cytidine and cytidine analogs. This prevents the breakdown of decitabine, increasing its bioavailability and efficacy while decreasing GI toxicity due to the administration of lower doses of decitabine. Decitabine exerts its antineoplastic activity through the incorporation of its triphosphate form into DNA, which inhibits DNA methyltransferase and results in hypomethylation of DNA. This interferes with DNA replication and decreases tumor cell growth. |
==Diseases for which it is used== | ==Diseases for which it is used== | ||
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * | + | *2020-07-07: Initial approval for adult patients with [[Myelodysplastic syndrome|myelodysplastic syndromes (MDS)]] including previously treated and untreated, de novo and secondary MDS with the following French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and [[chronic myelomonocytic leukemia|chronic myelomonocytic leukemia [CMML]]]) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups. ''(Based on ASTX727-01-B and ASCERTAIN)'' |
| − | + | ||
| − | + | ==History of changes in EMA indication== | |
| + | *2023-09-19: Initial marketing authorization as Inaqovi. Inaqovi is indicated as monotherapy for the treatment of adult patients with newly diagnosed [[Acute myeloid leukemia|acute myeloid leukaemia (AML)]] who are ineligible for standard induction chemotherapy. | ||
| + | |||
| + | == Patient Drug Information== | ||
| + | *[https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212576s000lbl.pdf Decitaine and cedazuridine (Inqovi) Package Insert]<ref>[https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212576s000lbl.pdf Decitaine and cedazuridine (Inqovi) Package Insert]</ref> | ||
==Also known as== | ==Also known as== | ||
| − | *'''Code name:''' | + | *'''Code name:''' ASTX-727 |
| − | *'''Brand name:''' Inqovi | + | *'''Brand name:''' Inaqovi, Inqovi |
| + | |||
| + | ==References== | ||
[[Category:Drugs]] | [[Category:Drugs]] | ||
| Line 19: | Line 25: | ||
[[Category:DNA methyltransferase inhibitors]] | [[Category:DNA methyltransferase inhibitors]] | ||
| − | [[Category:Pyrimidine | + | [[Category:Pyrimidine analogs]] |
[[Category:Chronic myelomonocytic leukemia medications]] | [[Category:Chronic myelomonocytic leukemia medications]] | ||
| Line 25: | Line 31: | ||
[[Category:FDA approved in 2020]] | [[Category:FDA approved in 2020]] | ||
| + | [[Category:EMA approved in 2023]] | ||
Latest revision as of 12:18, 1 October 2023
Mechanism of action
From the NCI Drug Dictionary: An orally available combination agent containing the cytidine deaminase (CDA) inhibitor E7727 and the cytidine antimetabolite decitabine, with potential antineoplastic activity. Upon oral administration of decitabine and cedazuridine, the CDA inhibitor E7727 binds to and inhibits CDA, an enzyme primarily found in the gastrointestinal (GI) tract and liver that catalyzes the deamination of cytidine and cytidine analogs. This prevents the breakdown of decitabine, increasing its bioavailability and efficacy while decreasing GI toxicity due to the administration of lower doses of decitabine. Decitabine exerts its antineoplastic activity through the incorporation of its triphosphate form into DNA, which inhibits DNA methyltransferase and results in hypomethylation of DNA. This interferes with DNA replication and decreases tumor cell growth.
Diseases for which it is used
History of changes in FDA indication
- 2020-07-07: Initial approval for adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS with the following French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia [CMML]) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups. (Based on ASTX727-01-B and ASCERTAIN)
History of changes in EMA indication
- 2023-09-19: Initial marketing authorization as Inaqovi. Inaqovi is indicated as monotherapy for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for standard induction chemotherapy.
Patient Drug Information
Also known as
- Code name: ASTX-727
- Brand name: Inaqovi, Inqovi