Difference between revisions of "Duvelisib (Copiktra)"
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**9/22/2022: ODAC has recommended withdrawal of this indication given detrimental extended follow-up efficacy data. | **9/22/2022: ODAC has recommended withdrawal of this indication given detrimental extended follow-up efficacy data. | ||
*9/24/2018: Accelerated approval for adult patients with relapsed or refractory [[Follicular lymphoma|follicular lymphoma (FL)]] after at least two prior systemic therapies. ''(Based on DYNAMO)'' | *9/24/2018: 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== | |
| + | *5/19/2021: Initial authorization | ||
==Also known as== | ==Also known as== | ||
*'''Code name:''' IPI-145 | *'''Code name:''' IPI-145 | ||
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[[Category:REMS program]] | [[Category:REMS program]] | ||
[[Category:FDA approved in 2018]] | [[Category:FDA approved in 2018]] | ||
| + | [[Category:EMA approved in 2021]] | ||
[[Category:Verastem Oncology compound]] | [[Category:Verastem Oncology compound]] | ||
Revision as of 14:55, 1 January 2023
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 (work in progress)
Patient drug information
History of changes in FDA indication
- 9/24/2018: 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)
- 9/22/2022: ODAC has recommended withdrawal of this indication given detrimental extended follow-up efficacy data.
- 9/24/2018: 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
- 5/19/2021: Initial authorization
Also known as
- Code name: IPI-145
- Brand name: Copiktra