The US Food and Drug Administration (FDA) has approved Astellas Pharma and Pfizer’s Padcev (enfortumab vedotin-ejfv) plus MSD’s Keytruda (pembrolizumab) to treat locally advanced or metastatic urothelial cancer (la/mUC) or bladder cancer. 

PADCEV is a nectin-4 protein-directed antibody-drug conjugate (ADC) while Keytruda is a programmed cell death protein 1 (PD-1) inhibitor.

This month, the FDA accepted MSD’s new supplemental biologics licence application (sBLA) for the combination regimen in la/mUC indication for review.

The approval has been granted based on data from the randomised, open-label, controlled Phase III EV-302 clinical trial, KEYNOTE-A39.

It enrolled 886 subjects with priorly untreated la/mUC who are eligible to receive cisplatin or carboplatin-containing chemotherapy irrespective of their PD-L1 status. 

The recommended dose of enfortumab vedotin-ejfv to be administered with pembrolizumab is 1.25mg/kg by intravenous infusion for 30 minutes on days one and eight of a 21-day cycle until the disease progresses or unacceptable toxicity is reached.

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According to the trial data, the Padcev combination regimen substantially improved median overall survival and progression-free survival versus platinum-based chemotherapy, meeting dual primary endpoints. 

This combination regimen was approved under an accelerated process in April 2023 for la/mUC patients who are not eligible to receive chemotherapy comprising cisplatin.

The combination regimen was indicated as an alternative option for platinum-containing chemotherapy, the existing first-line la/mUC standard of care.

The study served as the confirmatory trial for the accelerated approval of this indication.

All-grade adverse effects seen with the combination treatment included elevated aspartate aminotransferase, creatinine, glucose, lipase, peripheral neuropathy and lowered lymphocytes.

Astellas oncology development head and senior vice-president Ahsan Arozullah stated: “The FDA approval represents a paradigm change in the treatment of advanced bladder cancer and provides hope to the thousands of Americans impacted by this aggressive disease.

“This achievement is notable, as it is the first regimen approved in advanced urothelial cancer that has demonstrated superiority to platinum chemotherapy, the gold standard of care for decades.”