What is Padcev (enfortumab vedotin-ejfv) for?
Padcev (enfortumab vedotin-ejfv) is a Nectin-4-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adults with cancer of the urinary system (urothelial cancer). This type of cancer includes cancer of the bladder, renal pelvis, ureter or urethra that has spread (metastasized) to nearby tissues or to other areas of the body or cannot be removed by surgery (unresectable).1
It may be used by patients who have previously received an immunotherapy medicine and also received a chemotherapy-containing platinum medicine.1
It is available in vial form containing 20 mg or 30 mg enfortumab vedotin-ejfv.1
How does Padcev (enfortumab vedotin-ejfv) work?
Enfortumab vedotin-ejfv works differently from chemotherapy or immunotherapy because it is designed to deliver medicine directly to cancer cells.
It is an antibody-drug conjugate (ADC) that is made up of the antibody (a type of protein) IgG1 and a cytotoxic (anticancer) compound. IgG1 can bind to Nectin-4 on the surface of cancer cells. As a result, the cancer cell absorbs the medicine, and the cytotoxin kills the cancer cell, leaving the healthy cells intact.2,3
Where has Padcev (enfortumab vedotin-ejfv) been approved?
Padcev (enfortumab vedotin-ejfv) was approved for the treatment of advanced urothelial cancer by:
- The Food and Drug Administration (FDA), on December 18, 2019.4
It is a new type of therapy for patients with advanced urothelial cancer whose disease has progressed on chemotherapy and immunotherapy.4
Padcev was granted Accelerated Approval, and Priority Review and Breakthrough Therapy designations, in order to facilitate the (faster) development of promising therapies for diseases that not yet have sufficient treatment options.4
Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.
How is Padcev (enfortumab vedotin-ejfv) taken?
The standard dosage is:1
- 1.25 mg/kg (up to a maximum of 125 mg for patients ≥100 kg) given into the vein (intravenous infusion)
A dose of Padcev (enfortumab vedotin-ejfv) is given through a needle in the vein (intravenously) over 30 minutes.1
The treatment is given in cycles of 28 days. The patient receives the medicine on day 1, 8 and 15; one week in every treatment cycle is dose free.1
The healthcare provider will decide how many treatment cycles are needed, and may do regular blood tests during treatment.1
Complete information about Padcev (enfortumab vedotin-ejfv) dosage and administration can be found in the official prescribing information listed in our references section.1
Note: Please consult with your treating doctor for personalised dosing.
Are there any known adverse reactions or side effects of Padcev (enfortumab vedotin-ejfv)?
Common adverse reactions
The most common side effects (≥20% of patients) listed in the prescribing information include:1
- Numbness or tingling in hands or feet, or muscle weakness
- Tiredness (fatigue)
- Decreased appetite
- Rash
- Hair loss
- Nausea
- Diarrhea
- Change in sense of taste
- Dry eyes
- Dry skin
Serious adverse reactions
The serious adverse reactions listed in the prescribing information include:1
- High Blood Sugar (hyperglycemia)
- Peripheral neuropathy
- Eye problems
- Skin reactions
- Leakage of Padcev (enfortumab vedotin-ejfv) out of the vein into the tissues around the infusion site (extravasation)
Use in a specific population
Padcev (enfortumab vedotin-ejfv) can cause fetal harm when administered to a pregnant woman, it is advised to avoid pregnancies and breastfeeding. Your healthcare provider should do a pregnancy test before starting treatment. Patients should use birth control during the treatment, and for at least 3 week after the last dose.1
For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.1
References
1. Full prescribing information [FDA]: Padcev (enfortumab vedotin-ejfv) [PDF]
Astellas Pharma US Inc., Dec 18, 2019
2. Definition of enfortumab vedotin-ejfv
National Cancer Institute, cited on Nov 20, 2020
3. What is Padcev and how does it work?
Astellas, cited on Nov 20, 2020
4. FDA approves new type of therapy to treat advanced urothelial cancer
FDA press release, December 18, 2019