Enfortumab vedotin

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Enfortumab vedotin
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetNectin-4
Names
Trade namesPadcev
Other namesAGS-22M6E, AGS-22CE, enfortumab vedotin-ejfv
Clinical data
Drug classAntibody-drug conjugate[1]
Main usesUrothelial carcinoma[2]
Side effectsTiredness, peripheral nerve damage, decreased appetite, rash, hair loss, nausea, altered taste, diarrhea, kidney problems, low blood cells[3]
Routes of
use		Intravenous
Typical dose1.25 mg/kg[3]
External links
AHFS/Drugs.comMonograph
MedlinePlusa620005
Legal
License data
Legal status
Chemical and physical data
FormulaC6642H10284N1742O2063S46
Molar mass149024.23 g·mol−1

Enfortumab vedotin, sold under the brand name Padcev, is a medication used to treat urothelial carcinoma.[2] It is used in people who have at least advanced disease and have failed other treatments.[3] It is given by gradual injection into a vein.[2]

Common side effects include tiredness, peripheral nerve damage, decreased appetite, rash, hair loss, nausea, altered taste, diarrhea, kidney problems, and low blood cells.[3] Other side effects may include diabetic ketoacidosis, pneumonitis, eye problems, and Stevens-Johnson syndrome.[3] Use during pregnancy may harm the baby.[3] It is a monoclonal antibody attached to vedotin which is a microtubule-disrupting agent.[1] The monoclonal antibody attaches to nectin-4.[1]

Enfortumab vedotin was approved for medical use in the United States in 2019.[2] It is not approved in Europe or the United Kingdom as of 2021.[1] In the United States, for a person who weights 70 kg, the medication costs about 33,400 USD per 4 weeks.[4]

Medical uses

Dosage

It is given at a dose of 1.25 mg/kg up to a maximum of 125 mg.[3] This is given once a week for three weeks followed by a week off.[3]

History

Results of a Phase I clinical trial were reported in 2016.[5]

In December 2019, enfortumab vedotin-ejfv was approved in the United States for the treatment of adult patients with locally advanced or metastatic urothelial cancer who had previously received a programmed cell death receptor-1 (PD-1) or programmed death ligand 1 (PD-L1) inhibitor and a platinum-containing chemotherapy.[6][7]

Enfortumab vedotin was approved based on the results of a clinical trial that enrolled 125 patients with locally advanced or metastatic urothelial cancer who received prior treatment with a PD-1 or PD-L1 inhibitor and platinum-based chemotherapy.[6][7] The overall response rate, reflecting the percentage of patients who had a certain amount of tumor shrinkage, was 44%, with 12% having a complete response and 32% having a partial response.[6] The median duration of response was 7.6 months.[6]

The U.S. Food and Drug Administration (FDA) granted the application for enfortumab vedotin-ejfv accelerated approval, priority review designation, and breakthrough therapy designation.[6] The FDA granted the approval of Padcev to Astellas Pharma US Inc.[6]

In July 2021, the FDA approved enfortumab vedotin for adults with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand (PD-L1) inhibitor and platinum-containing chemotherapy, or; are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy.[8]

The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.[9]

References

  1. ↑ 1.0 1.1 1.2 1.3 "Enfortumab vedotin". SPS - Specialist Pharmacy Service. 10 September 2018. Archived from the original on 29 April 2021. Retrieved 15 December 2021.
  2. ↑ 2.0 2.1 2.2 2.3 "Enfortumab Vedotin-ejfv Monograph for Professionals". Drugs.com. Archived from the original on 11 December 2021. Retrieved 15 December 2021.
  3. ↑ 3.0 3.1 3.2 3.3 3.4 3.5 3.6 3.7 "DailyMed - PADCEV EJFV- enfortumab vedotin injection, powder, lyophilized, for solution". dailymed.nlm.nih.gov. Archived from the original on 11 December 2021. Retrieved 15 December 2021.
  4. ↑ "Padcev Prices, Coupons & Patient Assistance Programs". Drugs.com. Retrieved 15 December 2021.
  5. ↑ "Seattle Genetics and Agensys, an Affiliate of Astellas, Highlight Promising Enfortumab Vedotin (ASG-22ME) and ASG-15ME Phase 1 Data in Metastatic Urothelial Cancer at 2016 ESMO Congress. Oct 2016". Archived from the original on 26 December 2016. Retrieved 9 July 2021.
  6. ↑ 6.0 6.1 6.2 6.3 6.4 6.5 "FDA approves new type of therapy to treat advanced urothelial cancer". U.S. Food and Drug Administration (FDA) (Press release). 18 December 2019. Archived from the original on 19 December 2019. Retrieved 18 December 2019. Public Domain This article incorporates text from this source, which is in the public domain.
  7. ↑ 7.0 7.1 "Drug Trials Snapshots: Padcev". U.S. Food and Drug Administration (FDA). 13 December 2019. Archived from the original on 9 August 2020. Retrieved 24 January 2020. Public Domain This article incorporates text from this source, which is in the public domain.
  8. ↑ "FDA grants regular approval to enfortumab vedotin-ejfv for locally adv". U.S. Food and Drug Administration (FDA). 9 July 2021. Archived from the original on 9 July 2021. Retrieved 9 July 2021. Public Domain This article incorporates text from this source, which is in the public domain.
  9. ↑ "New Drug Therapy Approvals 2019". U.S. Food and Drug Administration. 31 December 2019. Archived from the original on 16 September 2020. Retrieved 15 September 2020.

External links

Identifiers:
  • "Enfortumab vedotin". Drug Information Portal. U.S. National Library of Medicine. Archived from the original on 20 January 2021. Retrieved 9 July 2021.
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