Difference between revisions of "Duvelisib (Copiktra)"
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m (Jwarner moved page Duvelisib (IPI-145) to Duvelisib (Copiktra): FDA approval) |
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==Mechanism of action== | ==Mechanism of action== | ||
| − | From [http://www.cancer.gov/publications/dictionaries/cancer-drug?CdrID=718963 NCI Drug Dictionary]: An orally bioavailable, highly selective and potent small molecule inhibitor of the delta and gamma isoforms of phosphoinositide-3 kinase (PI3K) with potential immunomodulating and antineoplastic activities. Upon administration, PI3K delta/gamma inhibitor IPI 145 prevents the activation of the PI3K delta/gamma-mediated signaling pathways which may lead to a reduction in cellular proliferation in PI3K delta/gamma-expressing tumor cells. Unlike other isoforms of PI3K, the delta and gamma isoforms are overexpressed primarily in hematologic malignancies and inflammatory and autoimmune diseases. By selectively targeting these PI3K isoforms, PI3K signaling in normal, non-neoplastic cells is minimally or not affected which would result in a more favorable side effect profile. | + | From [http://www.cancer.gov/publications/dictionaries/cancer-drug?CdrID=718963 NCI Drug Dictionary]: An orally bioavailable, highly selective and potent small molecule inhibitor of the delta and gamma isoforms of phosphoinositide-3 kinase (PI3K) with potential immunomodulating and antineoplastic activities. Upon administration, PI3K delta/gamma inhibitor IPI 145 prevents the activation of the PI3K delta/gamma-mediated signaling pathways which may lead to a reduction in cellular proliferation in PI3K delta/gamma-expressing tumor cells. Unlike other isoforms of PI3K, the delta and gamma isoforms are overexpressed primarily in hematologic malignancies and inflammatory and autoimmune diseases. By selectively targeting these PI3K isoforms, PI3K signaling in normal, non-neoplastic cells is minimally or not affected which would result in a more favorable side effect profile.<ref name="insert">[http://www.verastem.com/pdf/prescribing-information.pdf Duvelisib (Copiktra) package insert]</ref><ref>[[:File:Duvelisib.pdf | Duvelisib (Copiktra) package insert (locally hosted backup)]]</ref><ref>[https://www.copiktra.com/ Copiktra manufacturer's website]</ref> |
| + | |||
| + | ==Toxicity management== | ||
| + | *'''[http://www.copiktrarems.com/ REMS Program information here]''' | ||
| + | |||
| + | ==Diseases for which it is established== | ||
| + | *[[Chronic lymphocytic leukemia]] | ||
==Diseases for which it is used== | ==Diseases for which it is used== | ||
| − | |||
*[[Follicular lymphoma]] | *[[Follicular lymphoma]] | ||
| + | *[[Peripheral T-cell lymphoma]] | ||
| + | |||
| + | ==Patient drug information== | ||
| + | *[http://www.verastem.com/pdf/medication-guide.pdf Duvelisib (Copiktra) medication guide]<ref>[http://www.verastem.com/pdf/medication-guide.pdf Duvelisib (Copiktra) medication guide]</ref> | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * | + | *2018-09-24: Regular approval for adult patients with relapsed or refractory [[Chronic lymphocytic leukemia|chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)]] after at least two prior therapies. ''(Based on DUO)'' |
| − | * | + | *2018-09-24: Accelerated approval for adult patients with relapsed or refractory [[Follicular lymphoma|follicular lymphoma (FL)]] after at least two prior systemic therapies. ''(Based on DYNAMO)'' |
| + | ==History of changes in EMA indication== | ||
| + | *2021-05-19: Initial authorization | ||
==Also known as== | ==Also known as== | ||
*'''Code name:''' IPI-145 | *'''Code name:''' IPI-145 | ||
*'''Brand name:''' Copiktra | *'''Brand name:''' Copiktra | ||
| + | |||
| + | ==References== | ||
| + | <references/> | ||
[[Category:Drugs]] | [[Category:Drugs]] | ||
[[Category:Oral medications]] | [[Category:Oral medications]] | ||
| − | + | ||
[[Category:PI3K delta inhibitors]] | [[Category:PI3K delta inhibitors]] | ||
[[Category:PI3K gamma inhibitors]] | [[Category:PI3K gamma inhibitors]] | ||
| − | [[Category:Chronic lymphocytic leukemia | + | [[Category:Chronic lymphocytic leukemia medications]] |
[[Category:Follicular lymphoma medications]] | [[Category:Follicular lymphoma medications]] | ||
| + | [[Category:Peripheral T-cell lymphoma medications]] | ||
| + | [[Category:REMS program]] | ||
[[Category:FDA approved in 2018]] | [[Category:FDA approved in 2018]] | ||
| + | [[Category:EMA approved in 2021]] | ||
| + | [[Category:Verastem Oncology compound]] | ||
Latest revision as of 11:21, 9 April 2024
Mechanism of action
From NCI Drug Dictionary: An orally bioavailable, highly selective and potent small molecule inhibitor of the delta and gamma isoforms of phosphoinositide-3 kinase (PI3K) with potential immunomodulating and antineoplastic activities. Upon administration, PI3K delta/gamma inhibitor IPI 145 prevents the activation of the PI3K delta/gamma-mediated signaling pathways which may lead to a reduction in cellular proliferation in PI3K delta/gamma-expressing tumor cells. Unlike other isoforms of PI3K, the delta and gamma isoforms are overexpressed primarily in hematologic malignancies and inflammatory and autoimmune diseases. By selectively targeting these PI3K isoforms, PI3K signaling in normal, non-neoplastic cells is minimally or not affected which would result in a more favorable side effect profile.[1][2][3]
Toxicity management
Diseases for which it is established
Diseases for which it is used
Patient drug information
History of changes in FDA indication
- 2018-09-24: Regular approval for adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies. (Based on DUO)
- 2018-09-24: Accelerated approval for adult patients with relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. (Based on DYNAMO)
History of changes in EMA indication
- 2021-05-19: Initial authorization
Also known as
- Code name: IPI-145
- Brand name: Copiktra