LABELS · e8e304ca-8a56-4869-96e2-427ee4a1fe3c

PADCEV EJFV

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Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date: 2026-08-04
Captured: 2026-09-09T23:38:02.384588+00:00
Current indication reconciliation: Not reconciled

Boxed warning in this label

WARNING: SERIOUS SKIN REACTIONS • PADCEV can cause severe and fatal cutaneous adverse reactions including Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), which occurred predominantly during the first cycle of treatment, but may occur later. • Closely monitor patients for skin reactions. • Immediately withhold PADCEV and consider referral for specialized care for suspected SJS or TEN or severe skin reactions. • Permanently discontinue PADCEV in patients with confirmed SJS or TEN; or Grade 4 or recurrent Grade 3 skin reactions [see Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.1 ), and Adverse Reactions ( 6.1 )]. WARNING: SERIOUS SKIN REACTIONS See full prescribing information for complete boxed warning. • PADCEV can cause severe and fatal cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). • Immediately withhold PADCEV and consider referral for specialized care for suspected SJS or TEN or severe skin reactions. • Permanently discontinue PADCEV in patients with confirmed SJS or TEN; or Grade 4 or recurrent Grade 3 skin reactions. ( 2.2 ), ( 5.1 ), ( 6.1 )

Indications and usage: exact source text

1 INDICATIONS AND USAGE PADCEV ® , in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with muscle invasive bladder cancer (MIBC). PADCEV ® , in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC). PADCEV, as a single agent, is indicated for the treatment of adult patients with la/mUC who: • have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and platinum-containing chemotherapy, or • are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy. PADCEV is a Nectin-4-directed antibody and microtubule inhibitor conjugate indicated: • in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, for the treatment of adult patients with muscle invasive bladder cancer (MIBC). ( 1 ) • in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC). ( 1 ) • as a single agent for the treatment of adult patients with la/mUC who: ○ have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and platinum-containing chemotherapy, or ○ are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy. ( 1 )

Full extracted label fields

application numbers

BLA761137

boxed warning exact

WARNING: SERIOUS SKIN REACTIONS • PADCEV can cause severe and fatal cutaneous adverse reactions including Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), which occurred predominantly during the first cycle of treatment, but may occur later. • Closely monitor patients for skin reactions. • Immediately withhold PADCEV and consider referral for specialized care for suspected SJS or TEN or severe skin reactions. • Permanently discontinue PADCEV in patients with confirmed SJS or TEN; or Grade 4 or recurrent Grade 3 skin reactions [see Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.1 ), and Adverse Reactions ( 6.1 )]. WARNING: SERIOUS SKIN REACTIONS See full prescribing information for complete boxed warning. • PADCEV can cause severe and fatal cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). • Immediately withhold PADCEV and consider referral for specialized care for suspected SJS or TEN or severe skin reactions. • Permanently discontinue PADCEV in patients with confirmed SJS or TEN; or Grade 4 or recurrent Grade 3 skin reactions. ( 2.2 ), ( 5.1 ), ( 6.1 )

brand names

PADCEV EJFV

current indication status

not_reconciled

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https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b5631d3e-4604-4363-8f20-11dfc5a4a8ed

generic names

ENFORTUMAB VEDOTIN

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indications and usage exact

1 INDICATIONS AND USAGE PADCEV ® , in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with muscle invasive bladder cancer (MIBC). PADCEV ® , in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC). PADCEV, as a single agent, is indicated for the treatment of adult patients with la/mUC who: • have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and platinum-containing chemotherapy, or • are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy. PADCEV is a Nectin-4-directed antibody and microtubule inhibitor conjugate indicated: • in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, for the treatment of adult patients with muscle invasive bladder cancer (MIBC). ( 1 ) • in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC). ( 1 ) • as a single agent for the treatment of adult patients with la/mUC who: ○ have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and platinum-containing chemotherapy, or ○ are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy. ( 1 )

indications and usage tables exact

is original packager

true

manufacturer names

SEAGEN INC.

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cancer

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51144-030-01

product ndcs

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51144-030

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

Indications and Usage ( 1 ) 07/2026 Dosage and Administration ( 2.1 ) 07/2026 Warnings and Precautions ( 5.1 ), ( 5.3 ), ( 5.4 ) 07/2026

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Source passages and status connections

Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

Passage 1 · positive indication candidate

application numbers

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Passage 2 · positive indication candidate

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Passage 8 · unclassified context

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Passage 10 · unclassified context

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Passage 11 · positive indication candidate

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regulatory links

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source url

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use intent

non_oncology_or_unclear_candidate

Passage 12 · unclassified context

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source url

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use intent

unclear

Preserved source evidence · Not medical advice