EMJ Oncology 13 [Supplement 4] . 2025

This promotional material is fully sponsored and supported by Astellas Pharma Ltd. and is intended for healthcare professionals only.

Date of preparation: August 2025 │ MAT-GB-PAD-2025-00058

Prescribing information for PADCEV™ (enfortumab vedotin) is available below.

Indication: PADCEV™ (enfortumab vedotin), 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.

PADCEV™ (enfortumab vedotin) 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

▼This medicinal product is subject to additional monitoring

Prescribing Information: PADCEV™ (enfortumab vedotin) 20 mg and 30 mg powder for concentrate for solution for infusion

For full prescribing information refer to the Summary of Product Characteristics (SPC).

Presentation: One vial of padcev powder for concentrate for solution for infusion contains either 20 mg or 30 mg enfortumab vedotin. After reconstitution, each ml of solution contains 10 mg of enfortumab vedotin. Enfortumab vedotin is comprised of a fully human IgG1 kappa antibody, conjugated to the microtubule-disrupting agent monomethyl auristatin E (MMAE) via a protease-cleavable maleimidocaproyl valine-citrulline linker.

Indications: 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. 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 of the SPC).

Posology and method of administration: Treatment with padcev should be initiated and supervised by a physician experienced in the use of anti-cancer therapies. padcev is for intravenous use. It must not be administered as an intravenous push or bolus injection. Good venous access prior to starting treatment should be ensured (see section 4.4 of the SPC). As monotherapy, the recommended dose of enfortumab vedotin is 1.25 mg/kg (up to a maximum of 125 mg for patients ≥100 kg). It must be administered as an intravenous infusion over 30 minutes on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. When given in combination with pembrolizumab, the recommended dose of enfortumab vedotin is 1.25 mg/kg (up to a maximum of 125 mg for patients ≥100 kg) administered as an intravenous infusion over 30 minutes on Days 1 and 8 of every 3-week (21-day) cycle until disease progression or unacceptable toxicity. The recommended dose of pembrolizumab is either 200 mg every 3 weeks or 400 mg every 6 weeks administered as an intravenous infusion over 30 minutes. Patients should be administered pembrolizumab after enfortumab vedotin when given on the same day. Refer to the pembrolizumab SmPC for additional dosing information of pembrolizumab. For information on recommended dose reductions of enfortumab vedotin for adverse reactions as well as instructions on dose modifications (interruption, reduction and discontinuation) in patients experiencing adverse reactions refer to section 4.2 of the SPC. Special Populations: Elderly: No dose adjustment is necessary in patients ≥65 years of age (see section 5.2 of the SPC). Renal impairment: No dose adjustment is necessary in patients with mild [creatinine clearance (CrCL) >60-90 mL/min], moderate (CrCL 30–60 mL/min) or severe (CrCL 15–<30 mL/min) renal impairment. Enfortumab vedotin has not been evaluated in patients with end stage renal disease (CrCL <15 mL/min) (see section 5.2 of the SPC). Hepatic impairment: No dose adjustment is necessary in patients with mild hepatic impairment [total bilirubin of 1 to 1.5 × upper limit of normal (ULN) and aspartate transaminase (AST) any, or total bilirubin ≤ ULN and AST > ULN]. Enfortumab vedotin has only been evaluated in a limited number of patients with moderate and severe hepatic impairment. Hepatic impairment is expected to increase the systemic exposure to MMAE (the cytotoxic drug); therefore, patients should be closely monitored for potential adverse events. Due to the sparsity of the data in patients with moderate and severe hepatic impairment, no specific dose recommendation can be given (see section 5.2 of the SPC). Paediatric population: There is no relevant use of enfortumab vedotin in the paediatric population for the indication of locally advanced or metastatic urothelial cancer.

Contraindications: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the SPC.

Special warnings and precautions for use: Traceability: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Skin reactions: Skin reactions are associated with enfortumab vedotin as a result of enfortumab vedotin binding to Nectin-4 expressed in the skin. Fever or flu-like symptoms may be the first sign of a severe skin reaction, and patients should be observed, if this occurs. Mild to moderate skin reactions, predominantly rash maculo-papular, have been reported with enfortumab vedotin. The incidence of skin reactions occurred at a higher rate when enfortumab vedotin was given in combination with pembrolizumab compared to enfortumab vedotin as monotherapy (see section 4.8 of the SPC). Severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), with fatal outcome have also occurred in patients treated with enfortumab vedotin, predominantly during the first cycle of treatment. Patients should be monitored starting with the first cycle and throughout treatment for skin reactions. Appropriate treatment such as topical corticosteroids and antihistamines can be considered for mild to moderate skin reactions. For suspected SJS or TEN, or in case of bullous lesions onset, withhold treatment immediately and refer to specialised care; histologic confirmation, including consideration of multiple biopsies, is critical to early recognition, as diagnosis and intervention can improve prognosis. Permanently discontinue padcev for confirmed SJS or TEN, Grade 4 or recurrent Grade 3 skin reactions. For Grade 2 worsening, Grade 2 with fever or Grade 3 skin reactions, treatment should be withheld until Grade ≤1 and referral for specialised care should be considered. Treatment should be resumed at the same dose level or consider dose reduction by one dose level (see section 4.2 of the SPC). Pneumonitis/Interstitial Lung Disease (ILD): Severe, life-threatening or fatal pneumonitis/ILD have occurred in patients treated with enfortumab vedotin. The incidence of pneumonitis/ILD, including severe events occurred at a higher rate when enfortumab vedotin was given in combination with pembrolizumab compared to enfortumab vedotin as monotherapy (see section 4.8 of the SPC). Monitor patients for signs and symptoms indicative of pneumonitis/ILD such as hypoxia, cough, dyspnoea or interstitial infiltrates on radiologic exams. Corticosteroids should be administered for Grade ≥ 2 events (e.g., initial dose of 1-2 mg/kg/day prednisone or equivalent followed by a taper). Withhold padcev for Grade 2 pneumonitis/ILD and consider dose reduction. Permanently discontinue padcev for Grade ≥3 pneumonitis/ILD (see section 4.2 of the SPC). Hyperglycaemia: Hyperglycaemia and diabetic ketoacidosis (DKA), including fatal events, occurred in patients with and without pre- existing diabetes mellitus, treated with enfortumab vedotin (see section 4.8 of the SPC). Hyperglycaemia occurred more frequently in patients with pre-existing hyperglycaemia or a high body mass index (≥30 kg/m2). Patients with baseline HbA1c ≥8% were excluded from clinical studies. Blood glucose levels should be monitored prior to dosing and periodically throughout the course of treatment as clinically indicated in patients with or at risk for diabetes mellitus or hyperglycaemia. If blood glucose is elevated >13.9 mmol/L (>250 mg/dL), padcev should be withheld until blood glucose is ≤13.9 mmol/L (≤250 mg/dL) and treat as appropriate (see section 4.2 of the SPC). Serious infections: Serious infections such as sepsis (including fatal outcomes) have been reported in patients treated with padcev. Patients should be carefully monitored during treatment for the emergence of possible serious infections. Peripheral neuropathy: Peripheral neuropathy, predominantly peripheral sensory neuropathy, has occurred with enfortumab vedotin, including Grade ≥3 reactions (see section 4.8 of the SPC). Patients with pre-existing peripheral neuropathy Grade ≥2 were excluded from clinical studies. Patients should be monitored for symptoms of new or worsening peripheral neuropathy as these patients may require a delay, dose reduction or discontinuation of enfortumab vedotin. padcev should be permanently discontinued for Grade ≥3 peripheral neuropathy (see section 4.2 of the SPC). Ocular disorders: Ocular disorders, predominantly dry eye, have occurred in patients treated with enfortumab vedotin (see section 4.8 of the SPC). Patients should be monitored for ocular disorders. Consider artificial tears for prophylaxis of dry eye and referral for ophthalmologic evaluation if ocular symptoms do not resolve or worsen. Infusion site extravasation: Skin and soft tissue injury following enfortumab vedotin administration has been observed when extravasation occurred (see section 4.8 of the SPC). Ensure good venous access prior to starting padcev and monitor for possible infusion site extravasation during administration. If extravasation occurs, stop the infusion and monitor for adverse reactions. Embryo-foetal toxicity and contraception: Pregnant women should be informed of the potential risk to a foetus (see sections 4.6 and 5.3 of the SPC). Females of reproductive potential should be advised to have a pregnancy test within 7 days prior to starting treatment with enfortumab vedotin, to use effective contraception during treatment and for at least 6 months after stopping treatment. Men being treated with enfortumab vedotin are advised not to father a child during treatment and for at least 4 months following the last dose of padcev. Patient information pack: The prescriber must discuss the risks of padcev therapy, including combination therapy with pembrolizumab, with the patient. The patient should be provided with the patient information leaflet and patient card with each prescription.

Effects on ability to drive and use machines: padcev has no or negligible influence on the ability to drive and use machines.

Interactions: Formal drug-drug interaction studies with enfortumab vedotin have not been conducted. Caution is advised in case of concomitant treatment with CYP3A4 inhibitors. Patients receiving concomitant strong CYP3A4 inhibitors (e.g. boceprevir, clarithromycin, cobicistat, indinavir, itraconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole) should be monitored more closely for signs of toxicities. Strong CYP3A4 inducers (e.g. rifampicin, carbamazepine, phenobarbital, phenytoin, St John’s wort [Hypericum perforatum]) may decrease the exposure of unconjugated MMAE with moderate effect (see section 5.2 of the SPC).

Fertility, pregnancy and lactation: Women of childbearing potential/ Contraception in males and females: Refer to ‘Special warnings and precautions for use’ section above. Pregnancy: padcev can cause foetal harm when administered to pregnant women based upon findings from animal studies. padcev is not recommended during pregnancy and in women of childbearing potential not using effective contraception. Breast-feeding: Breast- feeding should be discontinued during padcev treatment and for at least 6 months after the last dose. Fertility: Men being treated with this medicinal product are advised to have sperm samples frozen and stored before treatment. There are no data on the effect of padcev on human fertility.

Undesirable effects: Summary of the safety profile: Enfortumab vedotin as monotherapy: The safety of enfortumab vedotin was evaluated as monotherapy in 793 patients who received at least one dose of enfortumab vedotin 1.25 mg/kg in two phase 1 studies (EV-101 and EV-102), three phase 2 studies (EV-103, EV-201 and EV-203) and one phase 3 study (EV-301) (see Table 3 in section 4.8 of the SPC). Patients were exposed to enfortumab vedotin for a median duration of 4.7 months (range: 0.3 to 55.7 months). The most common adverse reactions with enfortumab vedotin were alopecia (47.7%), decreased appetite (47.2%), fatigue (46.8%), diarrhoea (39.1%), peripheral sensory neuropathy (38.5%), nausea (37.8%), pruritus (33.4%), dysgeusia (30.4%), anaemia (29.1%), weight decreased (25.2%), rash maculo-papular (23.6%), dry skin (21.8%), vomiting (18.7%), aspartate aminotransferase increased (17%), hyperglycaemia, (14.9%), dry eye (12.7%), alanine aminotransferase increased (12.7%) and rash (11.6%). The most common serious adverse reactions (≥2%) were diarrhoea (2.1%) and hyperglycaemia (2.1%). Twenty-one percent of patients permanently discontinued enfortumab vedotin for adverse reactions; the most common adverse reaction (≥2%) leading to dose discontinuation was peripheral sensory neuropathy (4.8%). Adverse reactions leading to dose interruption occurred in 62% of patients; the most common adverse reactions (≥2%) leading to dose interruption were peripheral sensory neuropathy (14.8%), fatigue (7.4%), rash maculo-papular (4%), aspartate aminotransferase increased (3.4%), alanine aminotransferase increased (3.2%), anaemia (3.2%), hyperglycaemia (3.2%), neutrophil count decreased (3%), diarrhoea (2.8%), rash (2.4%) and peripheral motor neuropathy (2.1%). Thirty-eight percent of patients required a dose reduction due to an adverse reaction; the most common adverse reactions (≥2%) leading to a dose reduction were peripheral sensory neuropathy (10.3%), fatigue (5.3%), rash maculo-papular (4.2%) and decreased appetite (2.1%). Enfortumab vedotin in combination with pembrolizumab: When enfortumab vedotin is administered in combination with pembrolizumab, refer to the SPC for pembrolizumab prior to initiation of treatment. The safety of enfortumab vedotin was evaluated in combination with pembrolizumab in 564 patients who received at least one dose of enfortumab vedotin 1.25 mg/kg in combination with pembrolizumab in one phase 2 study (EV-103) and one phase 3 study (EV-302) (see Table 3). Patients were exposed to enfortumab vedotin in combination with pembrolizumab for a median duration of 9.4 months (range: 0.3 to 34.4 months). The most common adverse reactions with enfortumab vedotin in combination with pembrolizumab were peripheral sensory neuropathy (53.4%), pruritus (41.1%), fatigue (40.4%), diarrhoea (39.2%), alopecia (38.5%), rash maculo-papular (36%), weight decreased (36%), decreased appetite (33.9%), nausea (28.4%), anaemia (25.7%), dysgeusia (24.3%), dry skin (18.1%), alanine aminotransferase increased (16.8%), hyperglycaemia (16.7%), aspartate aminotransferase increased (15.4%), dry eye (14.4%), vomiting (13.3%), rash macular (11.3%), hypothyroidism (10.5%) and neutropenia (10.1%). The most common serious adverse reactions (≥2%) were diarrhoea (3%) and pneumonitis (2.3%). Thirty-six percent of patients permanently discontinued enfortumab vedotin for adverse reactions; the most common adverse reactions (≥2%) leading to discontinuation were peripheral sensory neuropathy (12.2%) and rash maculo-papular (2%). Adverse reactions leading to dose interruption of enfortumab vedotin occurred in 72% of patients. The most common adverse reactions (≥2%) leading to dose interruption were peripheral sensory neuropathy (17%), rash maculo-papular (6.9%), diarrhoea (4.8%), fatigue (3.7%), pneumonitis (3.7%), hyperglycaemia (3.4%), neutropenia (3.2%), alanine aminotransferase increased (3%), pruritus (2.3%) and anaemia (2%). Adverse reactions leading to dose reduction of enfortumab vedotin occurred in 42.4% of patients. The most common adverse reactions (≥2%) leading to dose reduction were peripheral sensory neuropathy (9.9%), rash maculo-papular (6.4%), fatigue (3.2%), diarrhoea (2.3%) and neutropenia (2.1%). Summary of adverse reactions: Adverse reactions observed during clinical studies of enfortumab vedotin as monotherapy or in combination with pembrolizumab, or reported from post-marketing use of enfortumab vedotin are listed in this section according to Medical Dictionary for Regulatory Activities (MedDRA) system organ classification by frequency category. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Frequency categories are defined as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). Infections and infestations: (monotherapy and in combination with pembrolizumab) Common: Sepsis. Blood and lymphatic system disorders: (monotherapy and in combination with pembrolizumab) Very common: Anaemia. Not known¹: Neutropenia, febrile neutropenia, neutrophil count decreased. Endocrine disorders: (in combination with pembrolizumab) Very common: Hypothyroidism. Metabolism and nutrition disorders: (monotherapy and in combination with pembrolizumab) Very common: Hyperglycaemia, decreased appetite. Not known¹: Diabetic ketoacidosis. Nervous system disorders: (monotherapy and in combination with pembrolizumab) Very common: Peripheral sensory neuropathy, dysgeusia. (monotherapy) Common: Neuropathy peripheral, peripheral motor neuropathy, peripheral sensorimotor neuropathy, paraesthesia, hypoaesthesia, gait disturbance, muscular weakness. (in combination with pembrolizumab) Common: Peripheral motor neuropathy, peripheral sensorimotor neuropathy, paraesthesia, hypoaesthesia, gait disturbance, muscular weakness. (monotherapy) Uncommon: Demyelinating polyneuropathy, polyneuropathy, neurotoxicity, motor dysfunction, dysaesthesia, muscle atrophy, neuralgia, peroneal nerve palsy, sensory loss, skin burning sensation, burning sensation. (in combination with pembrolizumab) Uncommon: Neurotoxicity, dysaesthesia, myasthenia gravis, neuralgia, peroneal nerve palsy, skin burning sensation. Eye disorders: (monotherapy and in combination with pembrolizumab) Very common: Dry eye. Respiratory, thoracic, and mediastinal disorders: (in combination with pembrolizumab) Very common: Pneumonitis/ILD². (monotherapy) Common: Pneumonitis/ILD². Gastrointestinal disorders: (monotherapy and in combination with pembrolizumab) Very common: Diarrhoea, vomiting, nausea. Skin and subcutaneous tissue disorders: (monotherapy) Very common: Alopecia, pruritus, rash, rash maculo-papular, dry skin. (in combination with pembrolizumab) Very common: Alopecia, pruritus, rash maculo-papular, dry skin, rash macular. (monotherapy) Common: Drug eruption, skin exfoliation, conjunctivitis, dermatitis bullous, blister, stomatitis, palmar-plantar erythrodysesthesia syndrome, eczema, erythaema, rash erythaematous, rash macular, rash papular, rash pruritic, rash vesicular. (in combination with pembrolizumab) Common: Rash, skin exfoliation, conjunctivitis, dermatitis bullous, blister, stomatitis, palmar-plantar erythrodysesthesia syndrome, eczema, erythaema, rash erythaematous, rash papular, rash pruritic, rash vesicular, erythaema multiforme, dermatitis. (monotherapy) Uncommon: Dermatitis exfoliative generalised, erythaema multiforme, exfoliative rash, pemphigoid, rash maculovesicular, dermatitis, dermatitis allergic, dermatitis contact, intertrigo, skin irritation, stasis dermatitis, blood blister. (in combination with pembrolizumab) Uncommon: Drug eruption, dermatitis exfoliative generalised, exfoliative rash, pemphigoid, dermatitis contact, intertrigo, skin irritation, stasis dermatitis. (monotherapy and in combination with pembrolizumab) Not known¹: TEN, SJS, epidermal necrosis, skin hyperpigmentation, skin discoloration, pigmentation disorder, symmetrical drug-related intertriginous and flexural exanthaema. Musculoskeletal and connective tissue disorders: (in combination with pembrolizumab) Common: Myositis. General disorders and administration site conditions: (monotherapy and in combination with pembrolizumab) Very common: Fatigue. (monotherapy and in combination with pembrolizumab) Common: Infusion site extravasation. Investigations: (monotherapy and in combination with pembrolizumab) Very common: Alanine aminotransferase increased, aspartate aminotransferase increased, weight decreased. (in combination with pembrolizumab) Common: Lipase increased. Injury, poisoning and procedural complications: (monotherapy and in combination with pembrolizumab) Common: Infusion related reaction.

¹Based on global post-marketing experience.

²Includes: acute respiratory distress syndrome, autoimmune lung disease, immune-mediated lung disease, interstitial lung disease, lung opacity, organizing pneumonia, pneumonitis, pulmonary fibrosis, pulmonary toxicity and sarcoidosis.

Description of selected adverse reactions. Immunogenicity: A total of 697 patients were tested for immunogenicity to enfortumab vedotin1.25 mg/kg as monotherapy; 16 patients were confirmed to be positive at baseline for anti-drug antibody (ADA), and in patients that were negative at baseline (N=681), a total of 24 (3.5%) were positive post baseline. A total of 490 patients were tested for immunogenicity against enfortumab vedotin following enfortumab vedotin in combination with pembrolizumab; 24 patients were confirmed to be positive at baseline for ADA, and in patients that were negative at baseline (N=466), a total of 14 (3%) were positive post baseline. The incidence of treatment-emergent anti-enfortumab vedotin antibody formation was consistent when assessed following enfortumab vedotin administration as monotherapy and in combination with pembrolizumab. Due to the limited number of patients with antibodies against padcev, no conclusions can be drawn concerning a potential effect of immunogenicity on efficacy, safety or pharmacokinetics. Skin reactions: In clinical studies of enfortumab vedotin as monotherapy, skin reactions occurred in 57% (452) of the 793 patients treated with enfortumab vedotin 1.25 mg/kg. Severe (Grade 3 or 4) skin reactions occurred in 14% (108) of patients and a majority of these reactions included rash maculo-papular, stomatitis, rash erythematous, rash or drug eruption. The median time to onset of severe skin reactions was 0.7 months (range: 0.1 to 8.2 months). Serious skin reactions occurred in 4.3% (34) of patients. Of the patients who experienced skin reactions and had data regarding resolution (N=366), 61% had complete resolution, 24% had partial improvement, and 15% had no improvement at the time of their last evaluation. Of the 39% of patients with residual skin reactions at last evaluation, 38% had Grade ≥2 events. In clinical studies of enfortumab vedotin in combination with pembrolizumab, skin reactions occurred in 70% (392) of the 564 patients and a majority of these skin reactions included rash maculo-papular, rash macular and rash papular. Severe (Grade 3 or 4) skin reactions occurred in 17% (97) of patients (Grade 3: 16%, Grade 4: 1%). The median time to onset of severe skin reactions was 1.7 months (range: 0.1 to 17.2 months). Of the patients who experienced skin reactions and had data regarding resolution (N=391), 59% had complete resolution, 30% had partial improvement, and 10% had no improvement at the time of their last evaluation. Of the 41% of patients with residual skin reactions at last evaluation, 27% had Grade ≥2 events. Pneumonitis/ILD: In clinical studies of enfortumab vedotin as monotherapy, pneumonitis/ILD occurred in 26 (3.3%) of the 793 patients treated with enfortumab vedotin 1.25 mg/kg. Less than 1% of patients experienced severe (Grade 3 or 4) pneumonitis/ILD (Grade 3: 0.5%, Grade 4: 0.3%). Pneumonitis/ILD led to discontinuation of enfortumab vedotin in 0.5% of patients. There were no deaths from pneumonitis/ILD. The median time to onset of any grade pneumonitis/ILD was 2.7 months (range: 0.6 to 6.0 months) and the median duration for pneumonitis/ILD was 1.6 months (range: 0.1 to 43.0 months). Of the 26 patients who experienced pneumonitis/ILD, 8 (30.8%) had resolution of symptoms. In clinical studies of enfortumab vedotin in combination with pembrolizumab, pneumonitis/ILD occurred in 58 (10.3%) of the 564 patients. Severe (Grade 3 or 4) pneumonitis/ILD occurred in 20 patients (Grade 3: 3.0%, Grade 4: 0.5%). Pneumonitis/ILD led to discontinuation of enfortumab vedotin in 2.1% of patients. Two patients experienced a fatal event of pneumonitis/ILD. The median time to onset of any grade pneumonitis/ILD was 4 months (range: 0.3 to 26.2 months). Hyperglycaemia: In clinical studies of enfortumab vedotin as monotherapy, hyperglycaemia (blood glucose >13.9 mmol/L) occurred in 17% (133) of the 793 patients treated with enfortumab vedotin 1.25 mg/kg. Serious events of hyperglycaemia occurred in 2.5% of patients, 7% of patients developed severe (Grade 3 or 4) hyperglycaemia and 0.3% of patients experienced fatal events, one event each of hyperglycaemia and diabetic ketoacidosis. The incidence of Grade 3-4 hyperglycaemia increased consistently in patients with higher body mass index and in patients with higher baseline haemoglobin A1C (HbA1c). The median time to onset of hyperglycaemia was 0.5 months (range: 0 to 20.3). Of the patients who experienced hyperglycaemia and had data regarding resolution (N=106), 66% had complete resolution, 19% had partial improvement, and 15% had no improvement at the time of their last evaluation. Of the 34% of patients with residual hyperglycaemia at last evaluation, 64% had Grade ≥2 events. Peripheral neuropathy: In clinical studies of enfortumab vedotin as monotherapy, peripheral neuropathy occurred in 53% (422) of the 793 patients treated with enfortumab vedotin 1.25 mg/kg. Five percent of patients experienced severe (Grade 3 or 4) peripheral neuropathy including sensory and motor events. The median time to onset of Grade ≥2 peripheral neuropathy was 5 months (range: 0.1 to 20.2). Of the patients who experienced neuropathy and had data regarding resolution (N=340), 14% had complete resolution, 46% had partial improvement, and 41% had no improvement at the time of their last evaluation. Of the 86% of patients with residual neuropathy at last evaluation, 51% had Grade ≥2 events. Ocular disorders: In clinical studies of enfortumab vedotin as monotherapy, 30% of patients experienced dry eye during treatment with enfortumab vedotin 1.25 mg/kg. Treatment was interrupted in 1.5% of patients and 0.1% of patients permanently discontinued treatment due to dry eye. Severe (Grade 3) dry eye only occurred in 3 patients (0.4%). The median time to onset of dry eye was 1.7 months (range: 0 to 30.6 months). Special populations: Elderly: Enfortumab vedotin in combination with pembrolizumab has been studied in 173 patients <65 years and 391 patients ≥65 years. Generally, adverse event frequencies were higher in patients ≥65 years of age compared to <65 years of age, particularly for serious adverse events (56.3%, and 35.3%, respectively) and Grade ≥3 events (80.3% and 64.2%, respectively), similar to observations with the chemotherapy comparator. Prescribers should consult the full SPC in relation to other adverse reactions.

Overdose: There is no known antidote for overdosage with enfortumab vedotin. In case of overdosage, the patient should be closely monitored for adverse reactions, and supportive treatment should be administered as appropriate taking into consideration the half-life of 3.6 days (ADC) and 2.6 days (MMAE).

Cost (excluding VAT): padcev 20 mg powder for concentrate for solution for infusion x 1 vial: £578

padcev 30 mg powder for concentrate for solution for infusion x 1 vial: £867

Legal classification: POM

Marketing Authorisation numbers:
padcev 20 mg powder for concentrate for solution for infusion PLGB 00166/0432.
padcev 30 mg powder for concentrate for solution for infusion PLGB 00166/0433.

Marketing Authorisation Holder:
Astellas Pharma Ltd. 300 Dashwood Lang Road, Bourne Business Park, Addlestone, United Kingdom, KT15 2NX.

Date of Preparation of Prescribing Information: February 2025

Job Bag Number: MAT-GB-PAD-2025-00017

Further information available from: Astellas Pharma Ltd, Medical Information 0800 783 5018. For full prescribing information, refer to the SPC, which may be found at: https://www.medicines.org.uk/emc. 

HCPs located in Europe, please refer to the EMA SmPC for PADCEV™ (enfortumab vedotin) via the following link: https://www.ema.europa.eu/en/documents/product-information/padcev-epar-product-information_en.pdf

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