Difference between revisions of "Duvelisib (Copiktra)"
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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>[[Media:Duvelisib.pdf | Duvelisib (Copiktra) package insert (locally hosted backup)]]</ref><ref>[https://www.copiktra.com/ Copiktra manufacturer's website]</ref> |
− | '''[http://www.copiktrarems.com/ REMS Program information here]''' | + | *'''[http://www.copiktrarems.com/ REMS Program information here]''' |
==Diseases for which it is used== | ==Diseases for which it is used== | ||
*[[Chronic lymphocytic leukemia (CLL/SLL)]] | *[[Chronic lymphocytic leukemia (CLL/SLL)]] | ||
*[[Follicular lymphoma]] | *[[Follicular lymphoma]] | ||
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+ | ==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== | ||
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*'''Code name:''' IPI-145 | *'''Code name:''' IPI-145 | ||
*'''Brand name:''' Copiktra | *'''Brand name:''' Copiktra | ||
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+ | ==References== | ||
+ | <references/> | ||
[[Category:Drugs]] | [[Category:Drugs]] |
Revision as of 06:31, 20 December 2018
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]
Diseases for which it is used
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."
- 9/24/2018: Accelerated approval "for adult patients with relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies."
Also known as
- Code name: IPI-145
- Brand name: Copiktra