Updated: January 11, 2026
What Is Padcev? Uses, Dosage, and What You Need to Know in 2026
Author
Peter Daggett

Overview
Padcev (enfortumab vedotin) is an FDA-approved antibody-drug conjugate for bladder and urothelial cancer. Learn what it is, how it's given, and what to expect in 2026.
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If you or someone you love has been diagnosed with bladder cancer or another urothelial cancer, your oncologist may have mentioned Padcev as part of your treatment plan. Padcev is a specialized cancer medicine that has transformed the treatment landscape for urothelial carcinoma — but it's a complex drug with a unique mechanism and administration that's unlike anything you may have taken before.
Here's a plain-English guide to what Padcev is, what it's approved for, how it's given, and what you can expect.
What Is Padcev?
Padcev is the brand name for enfortumab vedotin-ejfv, a prescription medicine in a category called antibody-drug conjugates (ADCs). ADCs are a cutting-edge type of cancer therapy that combines two components: a targeting antibody (which finds cancer cells) and a powerful cell-killing agent (which destroys them). Think of it as a guided missile that delivers chemotherapy directly to cancer cells while sparing healthy tissue.
Padcev was developed by Astellas Pharma in collaboration with Pfizer (formerly Seagen). It received its first FDA approval on December 18, 2019.
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What Is Padcev Approved to Treat?
As of 2026, Padcev is FDA-approved to treat adults with:
Muscle-invasive bladder cancer (MIBC): In combination with pembrolizumab (and berahyaluronidase alfa-pmph), as neoadjuvant treatment before surgery and adjuvant treatment after surgery, for patients who cannot receive cisplatin-containing chemotherapy
Locally advanced or metastatic urothelial cancer (la/mUC): In combination with pembrolizumab (and berahyaluronidase alfa-pmph), as a first-line or subsequent treatment option
Locally advanced or metastatic urothelial cancer (monotherapy): As a single agent for patients who have previously received a PD-1/PD-L1 inhibitor and platinum-based chemotherapy, or who are not eligible for cisplatin and have had at least one prior therapy
Urothelial cancer includes cancers of the bladder, ureter, renal pelvis, and urethra — anywhere cells line the urinary tract.
What Does Padcev Do to Cancer?
Padcev targets a protein called Nectin-4, which is found in high levels on the surface of urothelial cancer cells. The antibody part of Padcev locks onto the Nectin-4 protein, then the entire complex is taken inside the cancer cell. Once inside, enzymes within the cell break apart the linker that holds the drug together, releasing a powerful cell-killing agent called MMAE (monomethyl auristatin E). MMAE stops the cancer cell from being able to divide, causing it to die.
How Is Padcev Given?
Padcev is given through an IV (intravenous) infusion. It is not a pill or injection you take at home. Here's what the treatment schedule looks like:
Dose: 1.25 mg/kg (based on your body weight), up to a maximum of 125 mg if you weigh 100 kg or more
Schedule: Given on Days 1 and 8 of a 21-day cycle (approximately twice every three weeks)
Infusion time: Each dose is given over 30 minutes
Setting: Administered at a hospital infusion center, outpatient cancer center, or specialty infusion suite
When given with pembrolizumab, Padcev is administered approximately 30 minutes before the pembrolizumab infusion on the same day.
What Forms Does Padcev Come In?
Padcev comes as a lyophilized (freeze-dried) powder in single-dose vials for reconstitution and intravenous infusion:
20 mg per vial
30 mg per vial
Vials must be refrigerated (36°F–46°F). Do not freeze. Do not shake. The reconstituted solution is a clear to slightly opalescent, colorless to slightly yellow liquid.
How Effective Is Padcev?
The landmark EV-302/KEYNOTE-A39 clinical trial established Padcev as a new standard of care for locally advanced or metastatic urothelial cancer. Key results:
Median overall survival: 31.5 months (Padcev + pembrolizumab) vs 16.1 months (chemotherapy) — HR 0.47, p<0.0001
Median progression-free survival: 12.5 months vs 6.3 months — HR 0.45, p<0.0001
These results represent a significant improvement over prior standard-of-care chemotherapy and have made Padcev + pembrolizumab the preferred first-line regimen for most patients with locally advanced or metastatic urothelial cancer in 2026.
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Is Padcev a Controlled Substance?
No. Padcev is not a DEA-scheduled controlled substance. There are no special prescription requirements related to controlled substance regulations. However, it does require a valid prescription from a qualified oncology specialist and must be administered in a clinical setting.
If you've been prescribed Padcev and need help locating an infusion center near you, medfinder can search available facilities on your behalf.
Want to understand the science? Read: How Does Padcev Work? Mechanism of Action Explained in Plain English.
Frequently Asked Questions
Padcev treats urothelial carcinoma — cancer that starts in the cells lining the urinary tract, including the bladder, ureter, renal pelvis, and urethra. It is approved for locally advanced and metastatic forms of this cancer, as well as for muscle-invasive bladder cancer in the neoadjuvant/adjuvant setting in cisplatin-ineligible patients.
Padcev is technically an antibody-drug conjugate (ADC), not traditional chemotherapy. However, it does contain a powerful cytotoxic (cell-killing) agent called MMAE, which disrupts cell division like chemotherapy. The antibody component directs the MMAE to cancer cells specifically, allowing more targeted delivery than traditional chemo.
Padcev is given as a continuous treatment on Days 1 and 8 of 21-day cycles until disease progression or unacceptable toxicity. In the neoadjuvant/adjuvant MIBC setting, treatment cycles are time-limited (e.g., 4 neoadjuvant cycles, 5-6 adjuvant cycles). Your oncologist determines how long you continue based on how your cancer responds and how you tolerate treatment.
Padcev received its first FDA approval on December 18, 2019 (accelerated approval for previously treated locally advanced or metastatic urothelial cancer). Full approval for use with pembrolizumab in la/mUC was granted on December 15, 2023, based on superior overall survival data from the EV-302 trial.
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