Polatuzumab vedotin

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Polatuzumab vedotin
Monoclonal antibody
TypeWhole antibody
SourceHumanized (from mouse)
TargetCD79B
Names
Trade namesPolivy
Other namesDCDS4501A, RG7596, polatuzumab vedotin-piiq
Clinical data
Drug classAntibody-drug conjugate[1]
Main usesDiffuse large B-cell lymphoma[2]
Side effectsLow red blood cells, low platelets, low white blood cells, diarrhea, nausea, fever[3]
Pregnancy
category
Typical dose1.8 mg/kg[2]
External links
AHFS/Drugs.comMonograph
US NLMPolatuzumab vedotin
MedlinePlusa619039
Legal
License data
Legal status
  • AU: S4 (Prescription only)
  • US: ℞-only [5]
  • EU: Rx-only [6]
  • In general: ℞ (Prescription only)
Chemical and physical data
FormulaC6670H10317N1745O2087S40
Molar mass149627.43 g·mol−1

Polatuzumab vedotin, sold under the brand name Polivy, is a medication used to treat diffuse large B-cell lymphoma in combination with bendamustine and rituximab.[2] It is used when other treatments have not worked.[2] It is given by gradual injection into a vein.[2]

Common side effects include low red blood cells, low platelets, low white blood cells, diarrhea, nausea, and fever.[3] Other side effects may include peripheral neuropathy, infusion reaction, tumor lysis syndrome, liver problems, and infection.[2] Use in pregnancy may harm the baby.[2] It is a monoclonal antibody joined with monomethyl auristatin E (MMAE) that attaches to CD79b.[3]

Polatuzumab vedotin was approved for medical use in the United States in 2019 and Europe in 2020.[2][3] In the United Kingdom 140 mg costs the NHS about £11,000 as of 2021.[1] This amount in the United States costs about 15,700 USD.[7]

Medical uses

Dosage

It is given as a dose of 1.8 mg/kg every 21 days for a total of six doses.[2]

History

In June 2019, polatuzumab vedotin-piiq was approved in the United States in combination with the chemotherapy bendamustine and a rituximab product (a combination known as "BR"), to treat adult patients with diffuse large B-cell lymphoma (DLBCL) that has progressed or returned after at least two prior therapies.[8] Polatuzumab vedotin is a novel antibody-drug conjugate, and DLBCL is the most common type of non-Hodgkin lymphoma.[8]

The U.S. Food and Drug Administration (FDA) granted accelerated approval to polatuzumab vedotin used in combination with the chemotherapy bendamustine and a rituximab product.[8] Further clinical trials are required to verify and describe the clinical benefit of polatuzumab vedotin.[8]

The FDA approved polatuzumab vedotin based primarily on evidence from one clinical trial (NCT02257567)[9] that was conducted in the United States, Canada, Europe, and Asia.[10] Patients who participated in the trial had lymphoma that came back or did not improve after prior treatment.[10]

The FDA granted the application of polatuzumab vedotin-piiq breakthrough therapy designation, priority review designation, and orphan drug designation.[8] The FDA granted the approval of Polivy to Genentech.[8]

Polatuzumab vedotin was approved for medical use in the European Union in January 2020.[6] The European Medicines Agency (EMA) designated polatuzumab vedotin an orphan medicine in April 2018.[6]

References

  1. 1.0 1.1 BNF 81: March-September 2021. BMJ Group and the Pharmaceutical Press. 2021. p. 926. ISBN 978-0857114105.
  2. 2.0 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 "Polatuzumab Vedotin-piiq Monograph for Professionals". Drugs.com. Retrieved 28 October 2021.
  3. 3.0 3.1 3.2 3.3 "Polivy". Retrieved 28 October 2021.
  4. "Polivy Australian prescription medicine decision summary". Therapeutic Goods Administration (TGA). 13 December 2019. Retrieved 23 August 2020.
  5. "Polivy- polatuzumab vedotin injection, powder, lyophilized, for solution". DailyMed. 14 November 2019. Retrieved 23 August 2020.
  6. 6.0 6.1 6.2 "Polivy EPAR". European Medicines Agency (EMA). 27 January 2020. Retrieved 8 March 2020.
  7. "Polivy Prices, Coupons & Patient Assistance Programs". Drugs.com. Retrieved 28 October 2021.
  8. 8.0 8.1 8.2 8.3 8.4 8.5 "FDA approves first chemoimmunotherapy regimen for patients with relapsed or refractory diffuse large B-cell lymphoma". U.S. Food and Drug Administration (FDA) (Press release). 10 June 2019. Archived from the original on 25 November 2019. Retrieved 24 November 2019.Public Domain This article incorporates text from this source, which is in the public domain.
  9. Clinical trial number NCT02257567 for "A Study of Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab or Obinutuzumab Plus Bendamustine in Participants With Relapsed or Refractory Follicular or Diffuse Large B-Cell Lymphoma" at ClinicalTrials.gov
  10. 10.0 10.1 "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.Public Domain This article incorporates text from this source, which is in the public domain.

External links

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