Padcev, a Novel Targeted Therapy, FDA Approved for Advanced or Metastatic Urothelial Cancer

February 2020 Vol 13, Special Issue: Payers' Perspectives in Oncology - Drug Updates, FDA Approvals

On December 18, 2019, the FDA accelerated the approval of enfortumab vedotin-ejfv (Padcev; Astellas Pharma), a Nectin-4–directed antibody and microtubule inhibitor conjugate, for the treatment of adults with locally advanced or metastatic urothelial cancer after immunotherapy with a PD-1 or PD-L1 inhibitor and a platinum-containing chemotherapy. These are the current standard treatments for patients with bladder cancer, the sixth most common cancer in the United States. Urothelial cancer accounts for >90% of bladder cancers.

Enfortumab vedotin-ejfv represents a new type of therapy for patients with advanced urothelial cancer whose disease progressed during chemotherapy and immunotherapy. The FDA granted a breakthrough therapy designation to this therapy.

“Antibody-drug conjugates are strategic tools in the targeted treatment of cancer. These conjugates combine the ability of monoclonal antibodies to target specific receptors on cancer cells and then deliver a drug to the cancer cell,” said Richard Pazdur, MD, Director of the FDA’s Oncology Center of Excellence. “Padcev is an antibody-drug conjugate that targets Nectin-4, a cell surface protein expressed on bladder cancer cells and a cell-killing agent, monomethyl auristatin E.”

Enfortumab vedotin-ejfv was approved based on the results of a clinical trial of 125 patients with locally advanced or metastatic urothelial cancer who have received a PD-1 or PD-L1 inhibitor therapy and platinum-based chemotherapy.

The overall response rate was 44%, including 12% complete responses and 32% partial responses. The median duration of response to therapy with enfortumab vedotin-ejfv was 7.6 months.

The most common adverse events with enfortumab vedotin-ejfv were fatigue, peripheral neuropathy, decreased appetite, rash, alopecia, nausea, altered taste, diarrhea, dry eye, pruritis, and dry skin. Patients receiving this drug may have hyperglycemia, regardless of the presence of diabetes, as well as eye disorders, and the drug may cause harm to a fetus.

Related Items
Nubeqa Now Indicated for Metastatic Hormone-Sensitive Prostate Cancer
Web Exclusives published on December 14, 2022 in FDA Approvals
Imfinzi Receives New FDA Indication for Advanced or Metastatic Biliary Tract Cancer
Web Exclusives published on December 7, 2022 in FDA Approvals
Retevmo Receives New FDA Indication for Advanced Solid Tumors with RET Fusion
Web Exclusives published on November 30, 2022 in FDA Approvals
Imbruvica Now Also Indicated for Children with Chronic Graft-versus-Host Disease
Web Exclusives published on November 17, 2022 in FDA Approvals
Pemazyre Receives New Indication for FGFR1-­Positive Myeloid/Lymphoid Neoplasms
Web Exclusives published on November 17, 2022 in FDA Approvals
Last modified: August 30, 2021
Copyright © The Lynx Group, LLC. All rights reserved.