Difference between revisions of "Polatuzumab vedotin (Polivy)"
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==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)'' |
==History of changes in EMA indication== | ==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 | ||
| + | |||
==Also known as== | ==Also known as== | ||
*'''Code name:''' DCDS4501A | *'''Code name:''' DCDS4501A | ||
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[[Category:Drugs]] | [[Category:Drugs]] | ||
[[Category:Intravenous medications]] | [[Category:Intravenous medications]] | ||
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[[Category:Antibody-drug conjugates]] | [[Category:Antibody-drug conjugates]] | ||
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[[Category:Diffuse large B-cell lymphoma medications]] | [[Category:Diffuse large B-cell lymphoma medications]] | ||
| + | [[Category:FDA approved in 2019]] | ||
[[Category:EMA approved in 2020]] | [[Category:EMA approved in 2020]] | ||
| − | [[Category: | + | [[Category:Health Canada approved in 2020]] |
[[Category:Genentech product]] | [[Category:Genentech product]] | ||
Revision as of 01:35, 31 March 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)
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
Also known as
- Code name: DCDS4501A
- Generic name: polatuzumab vedotin-piiq
- Brand name: Polivy