Difference between revisions of "Polatuzumab vedotin (Polivy)"
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==Diseases for which it is used== | ==Diseases for which it is used== | ||
*[[Diffuse large B-cell lymphoma]] | *[[Diffuse large B-cell lymphoma]] | ||
| − | + | *[[High-grade B-cell lymphoma]] | |
==Patient drug information== | ==Patient drug information== | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * | + | *2019-06-10: Accelerated approval in combination with bendamustine and a rituximab product for adult patients with relapsed or refractory [[diffuse large B-cell lymphoma|diffuse large B-cell lymphoma (DLBCL), not otherwise specified]], after at least two prior therapies. ''(Based on GO29365)'' |
| + | *2023-04-19: Approved with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for adult patients who have previously untreated [[diffuse large B-cell lymphoma|diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS)]], or [[High-grade B-cell lymphoma|high-grade B-cell lymphoma (HGBL)]] and who have an International Prognostic Index (IPI) score of 2 or greater. ''(Based on POLARIX)'' | ||
| + | |||
| + | ==History of changes in EMA indication== | ||
| + | *2020-01-16: Initial conditional approval | ||
| + | ==History of changes in Health Canada indication== | ||
| + | *2020-07-09: Initial notice of compliance with conditions | ||
| + | *2023-01-20: Conditions were met | ||
| + | ==History of changes in PMDA indication== | ||
| + | *2021-03-21: Newly indicated for the treatment of relapsed or refractory [[diffuse large B-cell lymphoma]]. | ||
| + | *2022-08-24: New indication and a new dosage for the treatment of [[diffuse large B-cell lymphoma]]. | ||
==Also known as== | ==Also known as== | ||
| − | *'''Code name:''' DCDS4501A | + | *'''Code name:''' DCDS4501A, FCU-2711, RG-7596 |
*'''Generic name:''' polatuzumab vedotin-piiq | *'''Generic name:''' polatuzumab vedotin-piiq | ||
| − | *'''Brand name:''' Polivy | + | *'''Brand name:''' Polivy |
==References== | ==References== | ||
| Line 23: | Line 33: | ||
[[Category:Intravenous medications]] | [[Category:Intravenous medications]] | ||
| − | + | [[Category:Anti-CD79B antibody-drug conjugates]] | |
| − | [[Category: | ||
| − | |||
[[Category:Microtubule inhibitors]] | [[Category:Microtubule inhibitors]] | ||
[[Category:Diffuse large B-cell lymphoma medications]] | [[Category:Diffuse large B-cell lymphoma medications]] | ||
| − | + | [[Category:High-grade B-cell lymphoma medications]] | |
[[Category:FDA approved in 2019]] | [[Category:FDA approved in 2019]] | ||
| + | [[Category:EMA approved in 2020]] | ||
| + | [[Category:Health Canada approved in 2020]] | ||
| + | [[Category:PMDA approved in 2021]] | ||
[[Category:Genentech product]] | [[Category:Genentech product]] | ||
Latest revision as of 13:01, 8 September 2023
General information
Class/mechanism from the NCI Drug Dictionary: An antibody-drug conjugate (ADC) composed of a monoclonal antibody directed against B-cell antigen receptor complex-associated protein beta chain (CD79B) conjugated, via a protease-cleavable peptide linker, to monomethyl auristatin E (MMAE), an auristatin derivative and a potent microtubule inhibitor, with potential antineoplastic activity. Upon administration, polatuzumab vedotin selectively binds to CD79B, a protein which is abundantly expressed on the surface of B-cells. Upon internalization and proteolytic cleavage, MMAE binds to tubulin and inhibits its polymerization, resulting in G2/M phase arrest and tumor cell apoptosis.
Route: IV
Extravasation: neutral
Diseases for which it is used
Patient drug information
History of changes in FDA indication
- 2019-06-10: Accelerated approval in combination with bendamustine and a rituximab product for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, after at least two prior therapies. (Based on GO29365)
- 2023-04-19: Approved with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for adult patients who have previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), or high-grade B-cell lymphoma (HGBL) and who have an International Prognostic Index (IPI) score of 2 or greater. (Based on POLARIX)
History of changes in EMA indication
- 2020-01-16: Initial conditional approval
History of changes in Health Canada indication
- 2020-07-09: Initial notice of compliance with conditions
- 2023-01-20: Conditions were met
History of changes in PMDA indication
- 2021-03-21: Newly indicated for the treatment of relapsed or refractory diffuse large B-cell lymphoma.
- 2022-08-24: New indication and a new dosage for the treatment of diffuse large B-cell lymphoma.
Also known as
- Code name: DCDS4501A, FCU-2711, RG-7596
- Generic name: polatuzumab vedotin-piiq
- Brand name: Polivy