Polatuzumab vedotin

Polatuzumab vedotin
Monoclonal antibody
Type	Whole antibody
Source	Humanized (from mouse)
Target	CD79B
Clinical data
Trade names	Polivy
Other names	DCDS4501A, RG7596, polatuzumab vedotin-piiq
AHFS/Drugs.com	Monograph
MedlinePlus	a619039
License data	EU EMA: by INN; US DailyMed: Polatuzumab vedotin; US FDA: Polivy;
Pregnancy; category	AU: D; ;
ATC code	L01FX14 (WHO) ;
Legal status
Legal status	AU: S4 (Prescription only); CA: ℞-only / Schedule D; UK: POM (Prescription only); US: ℞-only; EU: Rx-only; In general: ℞ (Prescription only);
Identifiers
CAS Number	1313206-42-6;
IUPHAR/BPS	8404;
DrugBank	DB12240;
ChemSpider	none;
UNII	KG6VO684Z6;
KEGG	D10761;
Chemical and physical data
Formula	C6670H10317N1745O2087S40
Molar mass	149627.43 g·mol−1

Polatuzumab vedotin, sold under the brand name Polivy, is a CD79b-directed antibody-drug conjugate medication used for the treatment of diffuse large B-cell lymphoma (cancer).^[6] It was developed by the Genentech subsidiary of Roche.^[8]

The most common side effects include low levels of white blood cells (neutropenia), platelets (thrombocytopenia) and red blood cells (anemia); nerve damage (peripheral neuropathy); fatigue; diarrhea; fever; decreased appetite; and pneumonia.^[9]

Polatuzumab vedotin was approved for medical use in the United States in June 2019,^[9]^[10]^[11] in Australia in October 2019,^[1] in the European Union in January 2020,^[7] and in Canada in November 2020.^[3]

^ ^a ^b ^c "Polivy Australian prescription medicine decision summary". Therapeutic Goods Administration (TGA). 13 December 2019. Archived from the original on 5 March 2020. Retrieved 23 August 2020.
^ ^a ^b "AUSTRALIAN PRODUCT INFORMATION – POLIVY (polatuzumab vedotin)". Archived from the original on 12 July 2024. Retrieved 12 July 2024.
^ ^a ^b "Summary Basis of Decision (SBD) for Polivy". Health Canada. 23 October 2014. Archived from the original on 30 May 2022. Retrieved 29 May 2022.
^ "Polivy 30 mg powder for concentrate for solution for infusion - Summary of Product Characteristics (SmPC)". (emc). 20 July 2022. Archived from the original on 22 April 2023. Retrieved 22 April 2023.
^ "Polivy 140 mg powder for concentrate for solution for infusion - Summary of Product Characteristics (SmPC)". (emc). 20 July 2022. Archived from the original on 12 July 2024. Retrieved 22 April 2023.
^ ^a ^b "Polivy- polatuzumab vedotin injection, powder, lyophilized, for solution". DailyMed. 14 November 2019. Archived from the original on 22 October 2020. Retrieved 23 August 2020.
^ ^a ^b Cite error: The named reference Polivy EPAR was invoked but never defined (see the help page).
^ "FDA Grants Genentech's Polivy Accelerated Approval for People With Previously Treated Aggressive Lymphoma" (Press release). Genentech. 10 June 2019. Archived from the original on 17 February 2023. Retrieved 22 April 2023.
^ ^a ^b "FDA approves first chemoimmunotherapy regimen for patients with relapsed or refractory diffuse large B-cell lymphoma" (Press release). U.S. Food and Drug Administration (FDA). 10 June 2019. Archived from the original on 25 November 2019. Retrieved 24 November 2019. This article incorporates text from this source, which is in the public domain.
^ "Drug Approval Package: Polivy". U.S. Food and Drug Administration (FDA). 2 July 2019. Archived from the original on 30 October 2020. Retrieved 8 March 2020.
^ "Drug Trials Snapshots: Polivy". U.S. Food and Drug Administration (FDA). 17 June 2019. Archived from the original on 25 November 2019. Retrieved 24 November 2019. This article incorporates text from this source, which is in the public domain.

[Polivy_APMDS-1] "Polivy Australian prescription medicine decision summary". Therapeutic Goods Administration (TGA). 13 December 2019. Archived from the original on 5 March 2020. Retrieved 23 August 2020.

[Polivy_PI-2] "AUSTRALIAN PRODUCT INFORMATION – POLIVY (polatuzumab vedotin)". Archived from the original on 12 July 2024. Retrieved 12 July 2024.

[Canada_Polivy_SBD-3] "Summary Basis of Decision (SBD) for Polivy". Health Canada. 23 October 2014. Archived from the original on 30 May 2022. Retrieved 29 May 2022.

[4] "Polivy 30 mg powder for concentrate for solution for infusion - Summary of Product Characteristics (SmPC)". (emc). 20 July 2022. Archived from the original on 22 April 2023. Retrieved 22 April 2023.

[5] "Polivy 140 mg powder for concentrate for solution for infusion - Summary of Product Characteristics (SmPC)". (emc). 20 July 2022. Archived from the original on 12 July 2024. Retrieved 22 April 2023.

[Polivy_FDA_label-6] "Polivy- polatuzumab vedotin injection, powder, lyophilized, for solution". DailyMed. 14 November 2019. Archived from the original on 22 October 2020. Retrieved 23 August 2020.

[Polivy_EPAR-7] Cite error: The named reference Polivy EPAR was invoked but never defined (see the help page).

[8] "FDA Grants Genentech's Polivy Accelerated Approval for People With Previously Treated Aggressive Lymphoma" (Press release). Genentech. 10 June 2019. Archived from the original on 17 February 2023. Retrieved 22 April 2023.

[FDA_PR-9] "FDA approves first chemoimmunotherapy regimen for patients with relapsed or refractory diffuse large B-cell lymphoma" (Press release). U.S. Food and Drug Administration (FDA). 10 June 2019. Archived from the original on 25 November 2019. Retrieved 24 November 2019. This article incorporates text from this source, which is in the public domain.

[10] "Drug Approval Package: Polivy". U.S. Food and Drug Administration (FDA). 2 July 2019. Archived from the original on 30 October 2020. Retrieved 8 March 2020.

[FDA_Snapshot-11] "Drug Trials Snapshots: Polivy". U.S. Food and Drug Administration (FDA). 17 June 2019. Archived from the original on 25 November 2019. Retrieved 24 November 2019. This article incorporates text from this source, which is in the public domain.

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