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FDA Approves Powerful Duo: Enfortumab Vedotin-ejfv with Pembrolizumab

by MedOncMD on December 26, 2023

If you or a loved one is battling locally advanced or metastatic urothelial cancer (la/mUC), there’s groundbreaking news to share. On December 15, 2023, the Food and Drug Administration (FDA) gave the green light to a dynamic combination of treatments: enfortumab vedotin-ejfv (Padcev) and pembrolizumab (Keytruda). This approval is especially significant for patients ineligible for cisplatin-containing chemotherapy.

The Winning Combo: What You Need to Know

In a nutshell, enfortumab vedotin-ejfv with pembrolizumab has shown remarkable effectiveness in a recent trial involving 886 la/mUC patients who had not undergone prior systemic therapy for advanced disease. Picture it like a tag team wrestling match, where these two treatments join forces against cancer.

The trial’s key measurements were Overall Survival (OS) and Progression-Free Survival (PFS), evaluated through a meticulous review process. The results? A striking victory for the enfortumab vedotin-ejfv with pembrolizumab team.

  • Overall Survival: Patients receiving the winning combo saw a median survival of 31.5 months, compared to 16.1 months with platinum-based chemotherapy. That’s a significant difference, giving patients more time to live and thrive.
  • Progression-Free Survival: The enfortumab vedotin-ejfv with pembrolizumab team also excelled here, with a median PFS of 12.5 months, as opposed to 6.3 months for those receiving platinum-based chemotherapy. This means a longer period before the cancer starts advancing again.

What About Side Effects?

Every superhero has its quirks, and so does this powerful duo. The most common side effects observed in patients include increased aspartate aminotransferase, rash, fatigue, diarrhea, and more. It’s like the bumps and bruises a hero might get in a battle. Nothing unexpected, but it’s important for patients and caregivers to be aware.

Your Prescription Plan

For those embarking on this treatment journey, here’s the prescription playbook:

  • Enfortumab Vedotin-ejfv Dose: Administered intravenously over 30 minutes on Days 1 and 8 of a 21-day cycle until disease progression or unacceptable toxicity. It’s like receiving a boost of energy to combat the enemy.
  • Pembrolizumab Dose: Administered intravenously every 3 weeks or every 6 weeks until disease progression, unacceptable toxicity, or two years of therapy. Think of it as a strategic plan to keep the enemy at bay.

Behind the Scenes: How It All Happened

This monumental approval was part of Project Orbis, a global initiative for collaborative drug reviews. The FDA worked hand-in-hand with international partners, including the Australian Therapeutic Goods Administration and Health Canada, to fast-track this breakthrough.

The review process used innovative programs like the Real-Time Oncology Review pilot and the Assessment Aid, pushing the approval five months ahead of schedule. That’s like finishing a marathon way ahead of the expected time.

What’s Next?

This application received priority review and breakthrough designation, showcasing its exceptional promise. Healthcare professionals are encouraged to report any side effects through the FDA’s MedWatch Reporting System.

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About the author

Dr. Daniel Landau, a distinguished board-certified hematologist/oncologist, has built a commendable career spanning two eminent institutions: the Orlando Health Cancer Institute and the Medical University of South Carolina

Dr. Daniel Landau is a distinguished board-certified hematologist/oncologist renowned for his exceptional contributions in the field. With an illustrious career spanning across esteemed institutions like the Orlando Health Cancer Institute and the Medical University of South Carolina, Dr. Landau’s expertise shines in both genitourinary oncology and hematology.

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