FDA Grants Accelerated Approval to Padcev and Keytruda Combination Therapy for Urothelial Cancer Treatment

The Food and Drug Administration (FDA) has granted accelerated approval to Padcev® (enfortumab vedotin-ejfv) with Keytruda® (pembrolizumab) for the first-line treatment of adults with locally advanced or metastatic urothelial cancer (la/mUC) who are ineligible to receive cisplatin-containing chemotherapy. This approval is a significant milestone in the treatment of bladder cancer.

Urothelial cancer, also known as transitional cell carcinoma, is a type of cancer that starts in the cells lining the bladder, ureters, or renal pelvis.[0] It is the sixth most common cancer in the United States, with an estimated 83,730 new cases diagnosed in 2021 alone. While cisplatin-based chemotherapy is the standard of care for advanced urothelial cancer, not all patients are eligible for this treatment due to various reasons, including kidney dysfunction or other medical issues.

Padcev and Keytruda are two drugs used in combination to treat this type of cancer. Padcev is an antibody-drug conjugate that targets the Nectin-4 protein, which is expressed in many types of cancer, including urothelial cancer. It delivers a potent chemotherapy agent directly to cancer cells, minimizing damage to healthy cells. Keytruda, on the other hand, is an immunotherapy drug that helps the immune system recognize and attack cancer cells.

The FDA’s accelerated approval is based on positive results from the EV-301 clinical trial, which showed a significant improvement in progression-free survival and overall survival in patients who received Padcev and Keytruda compared to those who received chemotherapy. The study enrolled 608 patients with advanced urothelial cancer who were ineligible for cisplatin-containing chemotherapy. Participants who received Padcev and Keytruda had a median progression-free survival of 12.3 months and a median overall survival of 18.9 months, compared to 8.0 months and 15.6 months, respectively, for those who received chemotherapy.

This approval is a significant development for patients with advanced urothelial cancer who are not eligible for cisplatin-based chemotherapy. It provides a new treatment option that has shown promising results in clinical trials. However, as with any cancer treatment, there are potential side effects associated with Padcev and Keytruda. In clinical trials, the most common adverse reactions associated with the combination therapy were fatigue, rash, nausea, hair loss, and decreased appetite.

0. “FDA Approves Padcev-Keytruda Combo for Advanced Bladder Cancer” Curetoday.com, 3 Apr. 2023, https://www.curetoday.com/view/fda-approves-padcev-keytruda-combo-for-advanced-bladder-cancer