U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Development & Approval Process | Drugs
  4. Drug Approvals and Databases
  5. Resources for Information | Approved Drugs
  6. FDA D.I.S.C.O. Burst Edition: FDA approval of Padcev (enfortumab vedotin-ejfv) with Keytruda (pembrolizumab) for locally advanced or metastatic urothelial carcinoma
  1. Resources for Information | Approved Drugs

FDA D.I.S.C.O. Burst Edition: FDA approval of Padcev (enfortumab vedotin-ejfv) with Keytruda (pembrolizumab) for locally advanced or metastatic urothelial carcinoma


Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on a recent FDA cancer drug approval.

On April 3, 2023, the FDA granted accelerated approval to enfortumab vedotin-ejfv (brand name Padcev) with pembrolizumab (brand name Keytruda) for patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy.

Efficacy was evaluated in EV-103/KEYNOTE-869, a multi-cohort (dose escalation cohort, Cohort A, Cohort K) study. The dose escalation cohort and Cohort A were single-arm cohorts treating patients with enfortumab vedotin-ejfv plus pembrolizumab while patients on Cohort K were randomized to either the combination or to enfortumab vedotin-ejfv alone. Patients had not received prior systemic therapy for locally advanced or metastatic disease and were ineligible for cisplatin-containing chemotherapy. A total of 121 patients received enfortumab vedotin-ejfv plus pembrolizumab.

The major efficacy outcome measures were objective response rate and duration of response determined by blinded independent central review using RECIST v1.1. The confirmed objective response rate in 121 patients was 68%, including 12% with complete responses. The median duration of response for the dose escalation cohort + Cohort A was 22 months and for Cohort K was not reached.

The most common adverse reactions occurring in more than 20% of patients, including laboratory abnormalities, were increased glucose, increased aspartate aminotransferase, rash, decreased hemoglobin, increased creatinine, peripheral neuropathy, decreased lymphocytes, fatigue, increased alanine aminotransferase, decreased sodium, increased lipase, decreased albumin, alopecia, decreased phosphate, decreased weight, diarrhea, pruritus, decreased appetite, nausea, dysgeusia, decreased potassium, decreased neutrophils, urinary tract infection, constipation, potassium increased, calcium increased, peripheral edema, dry eye, dizziness, arthralgia, and dry skin.

This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.

Health care professionals should report serious adverse events to FDA’s MedWatch Reporting Program at www.fda.gov/medwatch.

Follow the Division of Drug Information on Twitter @FDA_Drug_Info and the Oncology Center of Excellence @FDAOncology. Send your feedback to FDAOncology@fda.hhs.gov. Thanks for tuning into the D.I.S.C.O. Burst Edition.

Back to Top