Padcev
Authorised
This medicine is authorised for use in the European Union
enfortumab vedotin
MedicineHumanAuthorised
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Padcev is a cancer medicine used in adults for treating:
urothelial cancer (a cancer of the bladder and urinary tract). It is used on its own in patients whose cancer is advanced or metastatic (has spread to other parts of the body) and who have already had platinum-based chemotherapy and an immunotherapy targeting PD-1 or PD-L1. Padcev can also be used in combination with pembrolizumab (another cancer medicine) when the cancer is metastatic or cannot be removed by surgery and patients have not been treated yet;
muscle invasive bladder cancer (MIBC), a type of cancer that has spread into or through the muscle layer of the bladder. It is used as a preliminary treatment to shrink the cancer (neoadjuvant treatment) before surgical removal of the bladder and then continued after surgery to lower the risk of the cancer coming back (adjuvant treatment). It is used in combination with pembrolizumab in adults for whom treatment with cisplatin-containing chemotherapy is not suitable.
It contains the active substance enfortumab vedotin.
Padcev can only be obtained with a prescription, and treatment should be started and supervised by a doctor experienced in the use of cancer medicines. Padcev is given as an infusion (drip) into a vein over 30 minutes. When Padcev is used on its own, the patient should have an infusion three times over the course of 28 days (on days 1, 8 and 15). When used with pembrolizumab, Padcev is given twice over the course of 21 days (on days 1 and 8).
Treatment should continue until the disease gets worse or the side effects become intolerable.
If the patient experiences severe side effects the doctor may stop treatment or reduce the dose. For more information about using Padcev, see the package leaflet or contact your doctor or pharmacist.
The active substance in Padcev, enfortumab vedotin, consists of an antibody (a type of protein) combined with another substance known as MMAE. The antibody first attaches to a protein on the surface of cancer cells to enter the cells. Once the active substance is inside the cells, MMAE disrupts the cells’ internal skeleton, causing cell death and helping to stop the cancer from getting worse or spreading.
Urothelial cancer
Padcev was more effective than chemotherapy at prolonging patients’ lives in a main study of 608 patients with advanced urothelial cancer who had already had platinum-based chemotherapy and an immunotherapy. In this study, patients treated with Padcev lived for a median of around 13 months while those who had chemotherapy lived for a median of 9 months.
Another study involving 886 patients with advanced or metastatic urothelial cancer who had not yet received treatment compared the benefits of Padcev in combination with pembrolizumab with those of platinum-based chemotherapy and gemcitabine (another cancer medicine). Patients treated with Padcev plus pembrolizumab lived for a median of around 13 months without the disease getting worse, and for a median of32 months overall. Patients treated with platinum-based chemotherapy and gemcitabine lived for a median of around 6 months without the disease getting worse, and for an average of around 16 months overall.
Muscle invasive bladder cancer (MIBC)
A main study showed that adults given Padcev in combination with pembrolizumab both before and after their bladder was surgically removed lived longer without their cancer worsening, returning, or causing complications when compared with adults who only had surgery. The study included adults with MIBC for whom treatment with cisplatin-based chemotherapy was not suitable. Results showed that 28% of patients who received Padcev together with pembrolizumab (48 out of 170) experienced an event, meaning their cancer worsened, returned, or led to other cancer-related complications. This compared with 55% of patients who only had surgery to remove the bladder and lymph nodes (95 out of 174).
Studies carried out with Padcev are described in more detail in the medicine’s assessment reports.
For the full list of side effects and restrictions with Padcev, see the package leaflet.
When Padcev is used on its own, the most common side effects (which may affect more than 1 in 10 people) include alopecia (hair loss), tiredness, reduced appetite, peripheral sensory neuropathy (nerve damage affecting sensation of pain, temperature and touch), diarrhoea, nausea (feeling sick), itching, dysgeusia (taste disturbance), anaemia (low red blood cell counts), weight loss, rash, dry skin, dry eyes, vomiting, increased levels of liver enzymes and hyperglycaemia (high blood glucose levels).
When Padcev is used in combination with pembrolizumab for the treatment of urothelial cancer or MIBC, the most common side effects include peripheral sensory neuropathy, itching, tiredness, diarrhoea, alopecia, rash, weight loss, decreased appetite, nausea, anaemia, dysgeusia, dry skin, increased levels of liver enzymes, hyperglycaemia and hypothyroidism (an underactive thyroid gland). Some side effects were reported in only one of these treatment settings.
When Padcev is used in combination with pembrolizumab for the treatment of urothelial cancer, dry eyes, vomiting and neutropenia (low levels of neutrophils, a type of white blood cell) also affect more than 1 in 10 people. When Padcev is used in combination with pembrolizumab for the treatment of MIBC, peripheral neuropathy (nerve damage in arms and legs) also affects more than 1 in 10 people.
At the time of approval, there were few treatment choices for patients with advanced or metastatic urothelial cancer. Padcev, on its own or in combination with pembrolizumab, was shown to prolong the lives of these patients. For patients with MIBC, the mainstay of treatment at the time of approval was cisplatin-based neoadjuvant chemotherapy followed by surgery. However, cisplatin-based chemotherapy was not suitable for up to 50% of patients with MIBC. In this context, Padcev given in combination with pembrolizumab was shown to improve the time patients lived without their MIBC worsening, returning or causing complications. However, due to the study design, it was not possible to determine the specific contribution of Padcev and pembrolizumab to the overall treatment effect or to distinguish the effects of treatment given before surgery from those of treatment given after surgery.
The side effects of Padcev were considered acceptable for a cancer medicine with the measures in place to minimise the risks.
The European Medicines Agency decided that Padcev’s benefits are greater than its risks and it can be authorised for use in the EU.
The company that markets Padcev will ensure that all healthcare professionals prescribing this medicine are given a patient information pack, which will include a patient card. The card will inform patients that treatment could cause severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis and advise them to seek immediate medical care if they have symptoms of these reactions.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Padcev have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Padcev are continuously monitored. Suspected side effects reported with Padcev are carefully evaluated and any necessary action taken to protect patients.
Padcev received a marketing authorisation valid throughout the EU on 13 April 2022.
Product information
Latest procedure affecting product information:VR/0000312495
19/06/2026
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Padcev
- Active substance
- Enfortumab vedotin
- International non-proprietary name (INN) or common name
- enfortumab vedotin
- Therapeutic area (MeSH)
- Carcinoma, Transitional Cell
- Urologic Neoplasms
- Anatomical therapeutic chemical (ATC) code
- L01FX13
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic indication
Muscle invasive bladder cancer (MIBC)
Padcev, in combination with pembrolizumab, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with resectable muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy.
Unresectable or metastatic urothelial cancer
Padcev, in combination with pembrolizumab, is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial cancer who are eligible for platinum-containing chemotherapy.
Locally advanced or metastatic urothelial cancer
Padcev as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a programmed death receptor‑1 or programmed death‑ligand 1 inhibitor (see section 5.1).
News on Padcev
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