Polatuzumab vedotin (Polivy)

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

• Diffuse large B-cell lymphoma
• High-grade B-cell lymphoma

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