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FDA Approval: Enfortumab vedotin (Padcev) for Bladder Cancer
FDA approved Enfortumab vedotin (Padcev), an antibody-drug conjugate, for certain people with bladder cancer. What was approved, the evidence, and what it does and doesn't mean.
Original commentary from the Cancer Explained editorial team.
Please note: this page is educational only — it is not medical advice, and it does not speculate about anyone’s health beyond reliable public reporting. For questions about your own health, talk with your healthcare team.
A guided missile, not a broadcast
Enfortumab vedotin, sold as Padcev, is an antibody-drug conjugate. That name describes the design. An antibody is joined by a chemical linker to a chemotherapy drug.
The antibody half is aimed at nectin-4, a protein that sits on the surface of most bladder cancer cells. The drug half is monomethyl auristatin E, or MMAE, which wrecks the internal scaffolding a cell needs in order to divide.
The label describes the sequence. The antibody sticks to nectin-4. The cell pulls the whole package inside. An enzyme snips the linker and frees MMAE. The cell's scaffolding falls apart and the cell dies.
The point of the design is delivery. MMAE is far too toxic to give on its own. Tied to an antibody, most of it goes where nectin-4 is. NCI notes that because nectin-4 sits on the majority of bladder cancers, no separate test is needed to decide who is eligible. That is unusual for a targeted drug. Our page on targeted therapy explains why most others do need one.
From last resort to first line
FDA granted accelerated approval on December 18, 2019. It was for advanced bladder cancer that had already progressed through platinum chemotherapy and then through an immune checkpoint inhibitor.
The evidence was a 125-person group in a trial called EV-201. Every participant got the drug; there was no comparison arm. Tumors shrank or stopped growing in 55 people, which is 44%, and 15 of those had no detectable tumor left. Responses lasted a median of 7.6 months. At the time, the usual third option was taxane chemotherapy, which a Duke oncologist quoted by NCI said worked in fewer than 10% of patients.
Four years later the drug moved to the front of the queue. On December 15, 2023, FDA approved enfortumab vedotin with pembrolizumab for locally advanced or metastatic urothelial cancer with no prior treatment for advanced disease.
That decision rested on EV-302, a randomized trial in 886 people. Half got the combination; half got standard platinum chemotherapy. Median overall survival was 31.5 months with the combination and 16.1 months with chemotherapy, a hazard ratio of 0.47. Median progression-free survival was 12.5 months against 6.3 months.
Doubling median survival in a first-line trial is rare. It is also why this approval changed practice rather than adding an option.
The label has since grown again. As revised in July 2026 it also covers muscle-invasive bladder cancer, given with pembrolizumab before surgery and continued after the bladder is removed.
What taking it is like
It is an intravenous infusion, not a tablet. With pembrolizumab it is given over about 30 minutes on days 1 and 8 of every 21-day cycle, at a weight-based amount the team calculates and caps.
The boxed warning, the strongest warning FDA uses, is for serious skin reactions. These include Stevens-Johnson syndrome and toxic epidermal necrolysis, in which the skin blisters and peels away. The label instructs teams to stop the drug immediately if either is suspected, and permanently if confirmed.
Peripheral neuropathy is the side effect most people notice day to day. It means nerve damage in the hands and feet, felt as numbness, tingling, burning or weakness. In the muscle-invasive setting the label reports any-grade neuropathy in 42% of 570 patients, with a median time to moderate neuropathy of 4.9 months. Among those with follow-up data, 41% recovered fully and 59% still had some.
The label also warns about high blood sugar, lung inflammation, eye problems including dry eye, and tissue damage if the infusion leaks out of the vein.
Where it fits alongside everything else
Drugs are one part of bladder cancer care. NCI describes surgery as the main treatment: transurethral resection for tumors that have not reached the muscle, partial cystectomy for some contained tumors, and radical cystectomy with urinary diversion when the muscle is involved.
Checkpoint inhibitors such as pembrolizumab release a brake on T cells rather than killing tumor cells directly, which is why pairing them with an antibody-drug conjugate made biological sense. Our pages on immunotherapy and on bladder cancer cover both halves.
When to get checked
Blood in the urine is the most common first sign of bladder cancer. NCI notes it can come and go, and can sometimes be found only by a test. Ask a doctor about:
- Blood in the urine, even once, even if it clears up.
- Needing to urinate often, or often at night.
- Pain or burning when passing urine.
- Feeling the urge to go when the bladder is not full.
- Lower back pain on one side, abdominal pain, bone pain, swollen feet, or weight loss you cannot explain.
Urinary infections and stones cause the same symptoms far more often than cancer does. The point is to have it looked at rather than to assume either way.
The wider numbers
American Cancer Society projections, published on SEER's bladder page, put 2026 at about 84,530 new bladder cancers and about 17,870 deaths in the United States. Five-year relative survival for 2016 to 2022 was 79.1% overall. Median age at diagnosis is 73.
Stage drives most of that. Half of cases are found in situ, meaning confined to the surface layer, where five-year relative survival is 98.0%. It is 73.0% for localized disease, 41.8% once regional nodes are involved, and 9.6% for distant disease, which accounts for 6% of cases. These are population figures from years already past and describe no individual.
What this approval cannot tell you
An approval says a drug met a regulatory bar for a defined group. It does not say the drug is right for one person, whose kidney function, nerve health, blood sugar, skin and other illnesses all bear on the decision.
Median survival is a midpoint. Half of people in EV-302 did better than the median and half did worse, and no trial figure predicts an individual result.
The 2019 accelerated approval also shows why early numbers need care. A 44% response rate in a single-arm study of 125 people is a promising signal, not proof of longer life. It took a randomized trial to show that.
Sources
- DailyMed, PADCEV (enfortumab vedotin-ejfv) prescribing information, revised July 2026 — https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b5631d3e-4604-4363-8f20-11dfc5a4a8ed
- FDA, FDA approves enfortumab vedotin-ejfv with pembrolizumab for locally advanced or metastatic urothelial cancer — https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-enfortumab-vedotin-ejfv-pembrolizumab-locally-advanced-or-metastatic-urothelial-cancer
- NCI Cancer Currents, Enfortumab Vedotin Approved for Advanced Bladder Cancer — https://www.cancer.gov/news-events/cancer-currents-blog/2020/enfortumab-vedotin-bladder-cancer-fda-approval
- NCI, Bladder Cancer Symptoms — https://www.cancer.gov/types/bladder/symptoms
- NCI, Bladder Cancer Treatment (Patient Version) — https://www.cancer.gov/types/bladder/patient/bladder-treatment-pdq
- SEER Cancer Stat Facts, Bladder Cancer — https://seer.cancer.gov/statfacts/html/urinb.html
How this article was prepared
An AI-assisted editorial system helped prepare this page. No named medical reviewer has reviewed it unless one is listed.
The National Cancer Information Foundation publishes Cancer Explained. This page is for learning. It is not medical advice and does not suggest a test or treatment.
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Put the story in context
Prevention, possible warning signs, screening, and diagnosis
This story relates to Bladder cancer. The information below is general: it does not reveal anything else about a public person’s health, and not every point applies to every cancer. Personal advice depends on age, symptoms, family history, exposures, and medical history.
Prevention and risk reduction
Not every cancer can be prevented. Avoiding tobacco, protecting skin from ultraviolet radiation, limiting alcohol, staying active, and receiving recommended HPV or hepatitis B vaccination can lower the risk of certain cancers. A risk factor is not a prediction or a cause in one individual.
Symptoms and possible early signs
Possible signs vary and are often caused by conditions other than cancer. Changes worth discussing include a new lump, unexplained bleeding or weight loss, a persistent cough, lasting bowel or bladder changes, a changing skin spot, or symptoms that persist or worsen. Some early cancers cause no symptoms.
Screening and early detection
Screening looks for certain cancers before symptoms begin. Recommended tests exist only for some cancers and depend on age and risk. Screening can have benefits and harms; it is not the same as evaluating a new symptom, and there is no single routine scan or blood test that reliably screens for every cancer.
How cancer is diagnosed
Diagnosis may involve a history and exam, imaging, laboratory tests, and often a biopsy. Pathology can identify the cancer type and may test biomarkers that guide treatment. Symptoms, screening results, tumor markers, or online stories alone cannot confirm cancer.
Learn about this story’s cancer topic
A public story may encourage questions, but it should not be used to estimate your risk or choose testing. Contact a healthcare professional about a persistent or concerning change. Seek urgent care for severe or rapidly worsening symptoms.