Approval of PADCEV™ (enfortumab vedotin‑ejfv) by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with locally advance
We are excited to announce the approval of PADCEV™ (enfortumab vedotin‑ejfv) by the U.S. Food and Drug
Administration (FDA) for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC)
who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor,
and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting.
This indication is approved under accelerated approval based on tumor response rate. Continued approval may be
contingent upon verification and description of clinical benefit in confirmatory trials.
PADCEV is now the first treatment option FDA approved for adult patients in this post platinum, post PD-1/L1
Important Safety Information
Warnings and Precautions
Hyperglycemia occurred in patients treated with PADCEV, including death and diabetic ketoacidosis (DKA), in those
with and without pre-existing diabetes mellitus. The incidence of Grade 3-4 hyperglycemia increased consistently
in patients with higher body mass index and in patients with higher baseline A1C. In one clinical trial, 8% of patients
developed Grade 3-4 hyperglycemia. Patients with baseline hemoglobin A1C ≥8% were excluded. Closely monitor
blood glucose levels in patients with, or at risk for, diabetes mellitus or hyperglycemia. If blood glucose is elevated
(>250 mg/dL), withhold PADCEV.
Peripheral neuropathy (PN), predominantly sensory, occurred in 49% of the 310 patients treated with PADCEV in
clinical trials; 2% experienced Grade 3 reactions. In one clinical trial, peripheral neuropathy occurred in patients treated
with PADCEV with or without preexisting peripheral neuropathy. The median time to onset of Grade ≥2 was 3.8 months
(range: 0.6 to 9.2). Neuropathy led to treatment discontinuation in 6% of patients. At the time of their last evaluation,
19% had complete resolution, and 26% had partial improvement. Monitor patients for symptoms of new or worsening
peripheral neuropathy and consider dose interruption or dose reduction of PADCEV when peripheral neuropathy
occurs. Permanently discontinue PADCEV in patients that develop Grade ≥3 peripheral neuropathy.
Ocular disorders occurred in 46% of the 310 patients treated with PADCEV. The majority of these events involved
the cornea and included keratitis, blurred vision, limbal stem cell deficiency and other events associated with dry eyes.
Dry eye symptoms occurred in 36% of patients, and blurred vision occurred in 14% of patients, during treatment
with PADCEV. The median time to onset to symptomatic ocular disorder was 1.9 months (range: 0.3 to 6.2). Monitor
patients for ocular disorders. Consider artificial tears for prophylaxis of dry eyes and ophthalmologic evaluation if ocular
symptoms occur or do not resolve. Consider treatment with ophthalmic topical steroids, if indicated after an ophthalmic
exam. Consider dose interruption or dose reduction of PADCEV for symptomatic ocular disorders.
Please see additional Important Safety Information on the next page and click here for Full Prescribing Information.
NOW FDA APPROVED
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