Enfortumab Vedotin

Enfortumab vedotin is a prescription cancer medicine given by drip into a vein. It is an antibody-drug conjugate (ADC): an antibody that finds a protein called Nectin-4 on the surface of cancer cells, with a cell-killing chemical, monomethyl auristatin E (MMAE), chemically tied to it. The antibody is the delivery vehicle; monomethyl auristatin E is the payload. Once the medicine is pulled inside a cell that carries Nectin-4, the payload is cut loose and stops the cell from dividing.

Its main use is cancer of the urothelium, the lining of the bladder and the tubes that carry urine. This page covers how the medicine is built and how it works, the approvals by the United States Food and Drug Administration (FDA) and their dates, what each main trial found, and the side effects and safety facts reported in the trials and on the United States label. The Bladder Cancer page describes the disease itself, its stages and its other treatments; the Schistosoma and Bladder Cancer page covers the parasite linked to one form of it.

Table of Contents

  1. What Enfortumab Vedotin Is
  2. How the Antibody Delivers Its Payload
  3. Nectin-4, the Target
  4. The FDA Approvals and Their Dates
  5. EV-101, the First Study in People
  6. EV-201, After Earlier Treatments Had Failed
  7. EV-301, Survival Compared With Chemotherapy
  8. EV-103, the First Pairing With Pembrolizumab
  9. EV-302, the Combination as First Treatment
  10. Before and After Bladder Surgery
  11. Skin Reactions and the Boxed Warning
  12. Nerve Damage
  13. High Blood Sugar
  14. Eyes, Lungs and the Other Label Warnings
  15. Where It Fits in Bladder Cancer Care
  16. What Is Not Known
  17. Key Research Papers
  18. Connections
  19. Featured Videos

What Enfortumab Vedotin Is

The United States label describes enfortumab vedotin as a fully human antibody of the immunoglobulin G1 type, aimed at Nectin-4, joined to monomethyl auristatin E through a chemical link that enzymes inside cells can cut. On average about four molecules of the payload hang on each antibody (the label gives a ratio of about 3.8 to 1), and the whole molecule weighs about 152 kilodaltons. The antibody is made in cultured hamster ovary cells, the usual factory cell for antibody medicines, and the payload and link are made by chemical synthesis and attached afterwards.

The word “vedotin” in the name marks the payload system: it is used for antibody medicines that carry monomethyl auristatin E on this kind of cleavable link. Another medicine built the same way is tisotumab vedotin, which carries the same payload to a different target on cervical cancer cells (see Cervical Cancer). The idea of a poison that rides a targeting molecule straight to the diseased cell goes back to the “magic bullet” of Paul Ehrlich; the antibodies that made it practical come from the work described on the Jerne, Köhler and Milstein page.

How the Antibody Delivers Its Payload

The label sets out the steps, based on laboratory work. First, the antibody binds to Nectin-4 on the outside of a cell. The cell then swallows the antibody together with the protein it is holding. Inside the cell, enzymes that break down proteins cut the link, and monomethyl auristatin E is set free.

Monomethyl auristatin E belongs to a group of chemicals that disrupt microtubules, the protein rods a cell uses to pull its copied chromosomes apart when it divides. With the rods broken up, the cell stops partway through division (the label calls this cell cycle arrest) and then undergoes programmed cell death, called apoptosis.

The payload is far too toxic to give on its own at a useful dose. The antibody is what limits most of it to cells that carry Nectin-4. That limit is not perfect: Nectin-4 is also found on some healthy tissues, which helps explain the skin side effects described below, and part of the payload reaches the bloodstream as free drug. The label also notes that in mice with tumors carrying Nectin-4, combining enfortumab vedotin with an antibody that blocks the immune checkpoint called programmed death-1 (PD-1) increased immune activity and anti-tumor effect — the laboratory reason for the later pairing with pembrolizumab.

Nectin-4, the Target

Nectin-4 is an adhesion protein, one of a family of molecules that help cells stick to their neighbours. The laboratory team that built the drug went looking for proteins found on cancer cells far more than on healthy tissue and picked Nectin-4. In 2016 they reported staining 2,394 tumor samples from bladder, breast, lung, pancreatic, ovarian, head and neck, and esophageal cancers: 69% of all samples were positive for Nectin-4, and moderate to strong staining was seen in 60% of bladder tumors and 53% of breast tumors, while the protein was found in a more limited way in normal tissue.

In the same paper, enfortumab vedotin bound Nectin-4 tightly and killed cells in the laboratory in a dose-dependent way. In mice carrying human breast, bladder, pancreatic and lung tumors, it slowed the growth of all four, and the breast and bladder tumors in mice shrank. These were animal and cell results; the human trials below are what led to approval.

Nectin-4 is also present in the skin. A 2022 review of the drug’s skin effects describes Nectin-4 in the outer skin cells (keratinocytes) and in sweat glands and hair follicles, and gives this as the expected reason skin reactions are common with the medicine.

The FDA Approvals and Their Dates

These are regulatory facts, taken from the FDA’s own announcements, its Drugs@FDA records for the biologics licence, and approval summaries written by FDA reviewers. The phrase “locally advanced or metastatic” below means cancer that has grown beyond the bladder wall into nearby tissue, or spread to other parts of the body, and cannot be removed by surgery alone.

“Muscle-invasive” means the cancer has grown into the muscle layer of the bladder wall but has not been found to have spread elsewhere. The two trial reports describe the earlier practice: cisplatin-based chemotherapy before surgery as a standard for people who could receive cisplatin, and surgery straight away for people who could not.

EV-101, the First Study in People

EV-101 was a phase 1 study, the first stage of testing in people, whose main purpose was to find a tolerable dose and measure safety. It enrolled people whose tumors carried Nectin-4, most of them with metastatic urothelial cancer, who had already had chemotherapy or an immune checkpoint medicine or both. Of the 155 people with urothelial cancer, 96% had already had platinum chemotherapy and 29% had had three or more earlier lines of treatment.

Doses were raised step by step up to 1.25 mg per kilogram of body weight on days 1, 8 and 15 of each 28-day cycle; a maximum tolerated dose was not reached, and 1.25 mg per kilogram was chosen for later trials. Among the 112 people with urothelial cancer who received that dose, 43% had their tumors shrink by a defined amount (the objective response rate), the responses lasted a median of 7.4 months, and median survival was 12.3 months. The most common side effects were rash, nerve damage in the hands and feet, tiredness, hair loss and nausea, mostly of grade 1 or 2 (mild or moderate).

EV-201, After Earlier Treatments Had Failed

EV-201 was a single-arm phase 2 trial: everyone received enfortumab vedotin and there was no comparison group. The trial gave 1.25 mg per kilogram by vein on days 1, 8 and 15 of each 28-day cycle. Response was judged by reviewers who did not know the patients.

Cohort 1: after platinum chemotherapy and immunotherapy

Cohort 1, published in 2019, treated 125 people whose cancer had already been treated with platinum chemotherapy and an immune checkpoint medicine. Their tumors shrank in 44%, including 12% whose visible tumors disappeared (complete responses). Similar response rates were seen in people with cancer in the liver and in people whose cancer had not responded to the earlier immunotherapy. The responses lasted a median of 7.6 months. The most common treatment-related side effects were tiredness (50%), any nerve damage (50%), hair loss (49%), any rash (48%), less appetite (44%) and a changed sense of taste (40%). This cohort was the basis of the 2019 accelerated approval; the FDA reviewers’ summary added that grade 3 or 4 (severe or life-threatening) side effects of any cause occurred in 73% of patients.

Cohort 2: people who could not receive cisplatin

Cohort 2, published in 2021, treated 89 people who had had an immune checkpoint medicine, had never had platinum chemotherapy for advanced disease, and were judged unable to receive cisplatin. The tumor shrank in 52%, with 20% complete responses. Severe treatment-related side effects occurred in 55%; the most common severe ones were a low count of the white blood cells called neutrophils (9%), a raised red rash (8%) and tiredness (7%). Three people died within 30 days of the first dose, from acute kidney injury, metabolic acidosis and multiple organ failure (one each), and the investigators judged these deaths treatment-related; a fourth treatment-related death, from lung inflammation, occurred more than 30 days after the last dose.

EV-301, Survival Compared With Chemotherapy

EV-301 was the confirmatory phase 3 trial. It enrolled 608 people with locally advanced or metastatic urothelial cancer that had grown after platinum chemotherapy and an immune checkpoint medicine, and assigned them at random either to enfortumab vedotin (the same 1.25 mg per kilogram on days 1, 8 and 15 of a 28-day cycle) or to a chemotherapy chosen by their doctor: docetaxel, paclitaxel or vinflunine. Neither the patients nor the doctors were blinded. The main question was overall survival.

At the planned interim analysis, after a median follow-up of 11.1 months, median survival was 12.88 months with enfortumab vedotin and 8.97 months with chemotherapy. The hazard ratio for death was 0.70, meaning about a 30% lower risk of death at any given time. Median time before the cancer grew (progression-free survival) was 5.55 versus 3.71 months. Treatment-related side effects were about as common in both groups (93.9% and 91.8%), and so were severe ones (51.4% and 49.8%).

A later analysis after a median of about two years (23.75 months) found the same hazard ratio for death, 0.70. The side effects differed in kind. Chemotherapy caused more severe drops in neutrophils (14.1% versus 6.1%), in white blood cells and in red blood cells. Enfortumab vedotin caused more severe raised rash (7.4% versus 0%), tiredness and nerve damage. Counting all grades, treatment-related skin reactions occurred in 47.3% with enfortumab vedotin and 15.8% with chemotherapy, nerve damage in 48.0% and 31.6%, and high blood sugar in 6.8% and 0.3%.

EV-103, the First Pairing With Pembrolizumab

Pembrolizumab is an immune checkpoint medicine: an antibody that blocks programmed death-1, a brake on the immune system’s T cells, so that they can attack the cancer. (The discovery behind this class is on the Allison and Honjo page.) EV-103, also called KEYNOTE-869, was a phase 1b/2 study with several groups (cohorts) that tested the two medicines together.

In cohort K, people with untreated locally advanced or metastatic urothelial cancer who could not receive cisplatin were assigned at random to enfortumab vedotin with pembrolizumab or to enfortumab vedotin alone, without a formal statistical comparison between the two. The tumor shrank in 64.5% of the 76 people on the combination and in 45.2% of the 73 on enfortumab vedotin alone. At 12 months, 65.4% and 56.3% of those who had responded were still responding. With the combination, the most common severe treatment-related side effects were raised rash (17.1%), tiredness (9.2%) and low neutrophils (9.2%); counting all grades, skin reactions occurred in 67.1% and nerve damage in 60.5%.

The FDA reviewers’ summary of the April 2023 approval pooled 121 people across cohorts who received the combination. The trial gave enfortumab vedotin 1.25 mg per kilogram on days 1 and 8 of a 21-day cycle with pembrolizumab 200 mg on day 1. The tumor shrank in 68%, 12% had complete responses, and the median response lasted 22 months. The reviewers wrote that the combination had the side effects of each medicine alone, but more often, including skin reactions, lung inflammation and nerve damage.

EV-302, the Combination as First Treatment

EV-302, also called KEYNOTE-A39, was the phase 3 trial that compared the combination with the standard first treatment for advanced urothelial cancer: gemcitabine with either cisplatin or carboplatin, depending on whether the person could receive cisplatin. Its abstract opens by noting that no treatment had beaten platinum-based chemotherapy for overall survival in this setting. The trial assigned 886 people with untreated locally advanced or metastatic urothelial cancer at random, 442 to the combination and 444 to chemotherapy, without blinding. The trial gave enfortumab vedotin 1.25 mg per kilogram on days 1 and 8 and pembrolizumab 200 mg on day 1 of each 3-week cycle.

After a median follow-up of 17.2 months, median progression-free survival was 12.5 months with the combination and 6.3 months with chemotherapy (hazard ratio 0.45), and median overall survival was 31.5 months versus 16.1 months (hazard ratio for death 0.47) — about twice as long. People in the combination group received a median of 12 cycles; chemotherapy was limited to a median of 6. Severe treatment-related side effects occurred in 55.9% with the combination and in 69.5% with chemotherapy. This trial was the basis of the December 2023 approval.

Before and After Bladder Surgery

For cancer that has invaded the bladder muscle but not spread, the usual operation is radical cystectomy: removal of the whole bladder together with nearby lymph nodes. Two phase 3 trials, both unblinded, tested whether giving enfortumab vedotin with pembrolizumab before the operation, and again after it, changes the outcome. Their main measure was event-free survival: the time until the cancer grew, came back or the person died, whichever came first.

KEYNOTE-905/EV-303: people who could not receive, or declined, cisplatin

This trial enrolled 344 people with muscle-invasive bladder cancer who could not receive or declined cisplatin-based chemotherapy. Half were assigned to the combination plus surgery: in all, 9 cycles of enfortumab vedotin (1.25 mg per kilogram on days 1 and 8) and 17 cycles of pembrolizumab (200 mg every 3 weeks), with the operation after the first 3 cycles. The other half had surgery alone, which was the usual care for this group. The operation was done in 87.6% and 89.7% of the two groups.

After a median follow-up of 25.6 months, estimated event-free survival at 2 years was 74.7% with the combination and 39.4% with surgery alone (hazard ratio 0.40), and estimated overall survival at 2 years was 79.7% and 63.1% (hazard ratio for death 0.50). No living tumor was found in the removed bladder (a pathological complete response) in 57.1% of the combination group and 8.6% of the surgery group. Side effects occurred in everyone in the combination group, severe ones in 71.3% and severe drug-related ones in 45.5%; in the surgery-alone group, 64.8% had side effects and 45.9% had severe ones.

KEYNOTE-B15/EV-304: people who could receive cisplatin

This trial enrolled 808 people who could receive cisplatin and compared the combination with the existing standard, 4 cycles of cisplatin with gemcitabine before surgery. The combination arm received 4 cycles of enfortumab vedotin with pembrolizumab before the operation and, after it, 5 more cycles of enfortumab vedotin and 13 of pembrolizumab. The operation was done in 86.7% and 89.6% of the two groups.

At 2 years, estimated event-free survival was 79.4% with the combination and 66.2% with cisplatin-gemcitabine (hazard ratio 0.53), and estimated overall survival was 86.9% and 81.3% (hazard ratio for death 0.65). No living tumor was found in the removed bladder in 55.8% and 32.5%. Severe side effects of any cause were more common with the combination: 75.7% versus 67.2%. The authors described the result as better survival “but with more adverse events of grade 3 or higher.”

Skin Reactions and the Boxed Warning

The United States label carries a boxed warning, the FDA’s strongest kind, headed “Serious skin reactions.” It states that the medicine can cause severe and fatal skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis — conditions in which large areas of skin and the linings of the mouth, eyes and genitals blister and peel (see Stevens-Johnson Syndrome). These occurred mostly during the first treatment cycle but can occur later. The boxed warning directs prescribers to stop the drug at once when either condition or another severe skin reaction is suspected, and to stop it for good when either is confirmed, or after a grade 4 or repeated grade 3 skin reaction.

The label gives the numbers. With pembrolizumab before and after surgery, skin reactions of any grade occurred in 65% of 570 people and severe ones in 13%; one person died of toxic epidermal necrolysis; the median time to a severe reaction was 0.6 months; and 8% stopped the drug because of skin reactions. With pembrolizumab in advanced cancer, skin reactions occurred in 70% of 564 people and severe ones in 17%, and one person died of a blistering skin reaction. The label states that skin reactions, including severe ones, were more frequent with the combination than with enfortumab vedotin alone. Most were rashes, often raised and red. Most cleared, but not all: in the surgery trials 13% of those with data still had a skin reaction at their last check.

Signs that hospitals treat as urgent include spreading blisters or peeling skin, sores in the mouth, eyes or genitals, and a rash with fever.

Nerve Damage

Damage to the long nerves of the hands and feet, called peripheral neuropathy, is one of the warnings on the label. It shows as numbness, tingling, burning or weakness, usually starting in the fingers and toes (see Peripheral Neuropathy).

In EV-301, nerve damage of any grade occurred in 48.0% with enfortumab vedotin and 31.6% with chemotherapy. On the label, with pembrolizumab before and after surgery, 42% of 570 people had nerve damage, 14% at grade 2 and 3% at grade 3, with a median time to grade 2 or worse of 4.9 months; of those with data, 59% still had nerve damage at their last check. With pembrolizumab in advanced cancer, 67% of 564 people had nerve damage, 36% at grade 2 and 7% at grade 3, and 87% of those with data still had it at their last check. The label states that nerve damage was more frequent with the combination than with the drug alone. People who already had moderate nerve damage were left out of EV-301, according to the label.

High Blood Sugar

The label states that high blood sugar (hyperglycemia) and diabetic ketoacidosis — a dangerous build-up of acids in the blood when the body cannot use sugar — occurred in people with and without diabetes, and that some of these events were fatal. In trials of the drug alone, 17% of 720 people developed high blood sugar and 7% had severe high blood sugar; one person died of high blood sugar and one of diabetic ketoacidosis. Severe high blood sugar was more frequent in people with a higher body mass index and in those with a higher starting hemoglobin A1C, a measure of average blood sugar over the previous months. It started a median of half a month after the first dose, and 5% of people needed insulin; two-thirds of those later stopped the insulin.

People with a hemoglobin A1C of 8% or more were excluded from the trials, so there is little information about people with poorly controlled diabetes. The label tells prescribers to withhold the drug when blood sugar is above 250 mg/dL. Signs that hospitals treat as urgent include heavy thirst and urination, vomiting, deep fast breathing and confusion.

Eyes, Lungs and the Other Label Warnings

Eyes

In trials of the drug alone where eye examinations were scheduled, the label reports eye problems in 40% of 384 people. Most involved the cornea, the clear front window of the eye, and were linked to dry eye: inflamed cornea (keratitis), blurred vision, watery eyes, conjunctivitis and damage to the stem cells at the edge of the cornea. Dry-eye symptoms occurred in 30% and blurred vision in 10%, starting a median of 1.7 months into treatment.

Lungs

The label reports severe, life-threatening or fatal lung inflammation (pneumonitis, also called interstitial lung disease). With the drug alone it occurred in 3% of 720 people. With pembrolizumab it was more frequent: 7% of 570 people before and after surgery, and 10% of 564 people with advanced cancer, two of whom died. A 2022 review of 64 Korean patients treated in EV-201 and EV-301 found lung inflammation in 18 (28.1%), of whom 2 died; 38.9% of the 18 had no symptoms and it was found on scans; it began a median of 13 weeks after the first dose. The authors could not rule out a role for the immunotherapy those patients had received before. Signs that hospitals treat as urgent include new or worsening cough, shortness of breath and low oxygen.

Other label facts

Where It Fits in Bladder Cancer Care

Within seven years the drug moved from a last option to a first one. In 2019 it was approved only after both platinum chemotherapy and immunotherapy had failed. In 2023, paired with pembrolizumab, it replaced platinum chemotherapy as an approved first treatment for advanced urothelial cancer. In 2025 and 2026 the same pair was approved for cancer still confined to the bladder, given around the operation to remove it.

The label defines who counts as unable to receive cisplatin, which decides which surgery-trial results apply: at least one of reduced kidney function (creatinine clearance below 60 mL per minute), limited ability to carry out daily activities, moderate hearing loss, advanced heart failure or moderate nerve damage. The KEYNOTE-905/EV-303 report notes that people in this group went straight to bladder removal, without treatment before it.

The Bladder Cancer page covers the disease’s stages, the other treatments — including treatment inside the bladder for early cancer, surgery and radiation — and the risk factors, among them smoking and long-term infection with the blood fluke Schistosoma haematobium (see Schistosoma and Bladder Cancer). The Bladder Cancer: History and Discovery page covers how its treatment developed.

What Is Not Known

Key Research Papers

  1. Challita-Eid PM, Satpayev D, Yang P, An Z, Morrison K, Shostak Y, et al. Enfortumab Vedotin Antibody-Drug Conjugate Targeting Nectin-4 Is a Highly Potent Therapeutic Agent in Multiple Preclinical Cancer Models. Cancer Res. 2016;76(10):3003-13. PubMed PMID: 27013195
  2. Rosenberg J, Sridhar SS, Zhang J, Smith D, Ruether D, Flaig TW, et al. EV-101: A Phase I Study of Single-Agent Enfortumab Vedotin in Patients With Nectin-4-Positive Solid Tumors, Including Metastatic Urothelial Carcinoma. J Clin Oncol. 2020;38(10):1041-1049. PubMed PMID: 32031899
  3. Rosenberg JE, O'Donnell PH, Balar AV, McGregor BA, Heath EI, Yu EY, et al. Pivotal Trial of Enfortumab Vedotin in Urothelial Carcinoma After Platinum and Anti-Programmed Death 1/Programmed Death Ligand 1 Therapy. J Clin Oncol. 2019;37(29):2592-2600. PubMed PMID: 31356140
  4. Yu EY, Petrylak DP, O'Donnell PH, Lee JL, van der Heijden MS, Loriot Y, et al. Enfortumab vedotin after PD-1 or PD-L1 inhibitors in cisplatin-ineligible patients with advanced urothelial carcinoma (EV‑201): a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2021;22(6):872-882. PubMed PMID: 33991512
  5. Chang E, Weinstock C, Zhang L, Charlab R, Dorff SE, Gong Y, et al. FDA Approval Summary: Enfortumab Vedotin for Locally Advanced or Metastatic Urothelial Carcinoma. Clin Cancer Res. 2021;27(4):922-927. PubMed PMID: 32962979
  6. Powles T, Rosenberg JE, Sonpavde GP, Loriot Y, Durán I, Lee JL, et al. Enfortumab Vedotin in Previously Treated Advanced Urothelial Carcinoma. N Engl J Med. 2021;384(12):1125-1135. PubMed PMID: 33577729
  7. Rosenberg JE, Powles T, Sonpavde GP, Loriot Y, Duran I, Lee JL, et al. EV-301 long-term outcomes: 24-month findings from the phase III trial of enfortumab vedotin versus chemotherapy in patients with previously treated advanced urothelial carcinoma. Ann Oncol. 2023;34(11):1047-1054. PubMed PMID: 37678672
  8. O'Donnell PH, Milowsky MI, Petrylak DP, Hoimes CJ, Flaig TW, Mar N, et al. Enfortumab Vedotin With or Without Pembrolizumab in Cisplatin-Ineligible Patients With Previously Untreated Locally Advanced or Metastatic Urothelial Cancer. J Clin Oncol. 2023;41(25):4107-4117. PubMed PMID: 37369081
  9. Maguire WF, Lee D, Weinstock C, Gao X, Bulik CC, Agrawal S, et al. FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma. Clin Cancer Res. 2024;30(10):2011-2016. PubMed PMID: 38441576
  10. Powles T, Valderrama BP, Gupta S, Bedke J, Kikuchi E, Hoffman-Censits J, et al. Enfortumab Vedotin and Pembrolizumab in Untreated Advanced Urothelial Cancer. N Engl J Med. 2024;390(10):875-888. PubMed PMID: 38446675
  11. Brave MH, Maguire WF, Weinstock C, Zhang H, Gao X, Li F, et al. FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Locally Advanced or Metastatic Urothelial Carcinoma. Clin Cancer Res. 2024;30(21):4815-4821. PubMed PMID: 39230571
  12. Vulsteke C, Adra N, Danchaivijitr P, Sabadash M, Rodriguez-Vida A, Zhang Z, et al. Perioperative Enfortumab Vedotin and Pembrolizumab in Bladder Cancer. N Engl J Med. 2026;394(13):1257-1269. PubMed PMID: 41707170
  13. Galsky MD, Valderrama BP, Maruzzo M, Font A, Ciuleanu T, Chatzkel J, et al. Enfortumab Vedotin and Pembrolizumab in Cisplatin-Eligible Bladder Cancer. N Engl J Med. 2026;395(4):338-348. PubMed PMID: 42485627
  14. Lacouture ME, Patel AB, Rosenberg JE, O'Donnell PH. Management of Dermatologic Events Associated With the Nectin-4-directed Antibody-Drug Conjugate Enfortumab Vedotin. Oncologist. 2022;27(3):e223-e232. PubMed PMID: 35274723
  15. Yoon S, Shin SJ, Kim HC, Kim YS, Lee HJ, Keam B, et al. Enfortumab vedotin-related pneumonitis is more common than expected and could lead to acute respiratory failure. Eur J Cancer. 2022;174:81-89. PubMed PMID: 35985251

Regulatory sources: the FDA approval notices of 3 April 2023, 15 December 2023, 21 November 2025 and 10 July 2026 (FDA oncology approval notifications); the Drugs@FDA record of the biologics licence, which lists the 18 December 2019 original approval and the efficacy supplements of 9 July 2021, 3 April 2023, 15 December 2023, 21 November 2025 and 10 July 2026; and the current United States prescribing information (revised August 2026).

PubMed Topic Searches

  1. Enfortumab vedotin
  2. Enfortumab vedotin with pembrolizumab, randomized trials
  3. Enfortumab vedotin in muscle-invasive bladder cancer
  4. Enfortumab vedotin and skin reactions
  5. Nectin-4 antibody-drug conjugates

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