FDA grants priority review to sBLA for Keytruda (pembrolizumab) + Padcev (enfortumab vedotin-ejfv) for the first-line treatment of locally advanced or metastatic urothelial cancer
Merck In.,known as MSD outside of the United States and Canada, announced that the FDA has accepted for priority review a new supplemental Biologics License Application (sBLA) seeking approval for Keytruda Merck’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv), an antibody-drug conjugate, for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (la/mUC)
This application is being reviewed under the FDA’s Real-Time Oncology Review (RTOR) program, which aims to improve the efficiency of the review process of applications to ensure that treatments are available to patients as early as possible. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of May 9, 2024.
The sBLA is based on data from the Phase III KEYNOTE-A39 trial (also known as EV-302), which was conducted in a research collaboration with Seagen and Astellas, in which Keytruda plus enfortumab vedotin demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) and progression-free survival (PFS) compared to chemotherapy (gemcitabine plus cisplatin or carboplatin). These results were presented at the European Society for Medical Oncology Congress 2023 as late-breaking data during a Presidential Symposium session and showed Keytruda plus enfortumab vedotin significantly improved OS, reducing the risk of death by 53% compared to chemotherapy (median OS, 31.5 months vs. 16.1 months, respectively), an improvement in median OS of more than 15 months; (HR=0.47 [95% CI, 0.38-0.58]; p<0.00001).
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