FDA Grants Priority Review for Enfortumab Vedotin-ejfv, Pembrolizumab for Treatment of Urothelial Cancer

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The FDA granted Priority Review to both applications and set a Prescription Drug User Fee Act goal date for each application of April 21, 2023.

The FDA has accepted a supplemental Biologics License Applications (sBLAs) to expand the labels for enfortumab vedotin-ejfv (Padcev) and pembrolizumab (Keytruda) for the first-line treatment of patients with locally advanced or metastatic urothelial cancer who are not eligible to receive cisplatin-containing chemotherapy. The FDA granted Priority Review to both applications and set a Prescription Drug User Fee Act goal date for each application of April 21, 2023.

“We look forward to working closely with the FDA as we seek potential accelerated approval for this combination in the hopes that it can be another treatment option for patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing chemotherapy,” said Ahsan Arozullah, MD, MPH, senior vice president and head of development therapeutic areas at Astellas, in a press release.

An estimated 81,108 individuals in the United States were diagnosed with bladder cancer in 2022. Urothelial cancer accounts for approximately 90% of all bladder cancers and can also be found in the renal pelvis, ureter, and urethra. Approximately 12% of cases are locally advanced or metastatic urothelial cancer at diagnosis.

The combination therapy was granted Breakthrough Therapy designation in February 2020. Each sBLA is supported by efficacy and safety data from the KEYNOTE-869 trial’s dose escalation/cohort A and cohort K. Results from cohort A were published in the Journal of Clinical Oncology and results from cohort K were presented in a late-breaking session at the 2022 European Society for Medical Oncology Congress.

“Urothelial cancer, the most common type of bladder cancer, is associated with poor survival in the advanced stage,” said Marjorie Green, MD, senior vice president and head of late-stage development at Seagen, in the press release. “The investigational results from our clinical development program support the combination of Padcev and Keytruda as a potential treatment for this patient population.”

KEYNOTE-869 is an ongoing, multi-cohort, open-label, multicenter phase 1b/2 trial of enfortumab vedotin alone or in combination with pembrolizumab, with or without chemotherapy, in first- or second-line settings in patients with locally advanced or metastatic urothelial cancer and in patients with muscle-invasive bladder cancer.

“Despite advancements in treatment options, approximately half of advanced bladder cancer patients in the US are ineligible for cisplatin-based chemotherapy, and these patients need new options,” said Eliav Barr, MD, senior vice president, head of global clinical development, and chief medical officer at Merck Research Laboratories, in the press release. “We are encouraged by the investigational results of the combination of Padcev and Keytruda for this patient population and are fully committed to work to bring this new approach forward to patients.”

The companies are also investigating the combination in the ongoing phase 3 KEYNOTE-A39 study, which is examining the clinical benefit for the combination in patients with previously untreated advanced urothelial cancer. This is intended to be a confirmatory trial for the potential accelerated approval in the United States and the basis for global registration.

REFERENCE

Seagen, Astellas and Merck Announce FDA Acceptance of sBLAs for Padcev (enfortumab vedotin-ejfv) with Keytruda (pembrolizumab) for the First-Line Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer. News release. Seagen; December 20, 2022. Accessed December 20, 2022. https://investor.seagen.com/press-releases/news-details/2022/Seagen-Astellas-and-Merck-Announce-FDA-Acceptance-of-sBLAs-for-PADCEV-enfortumab-vedotin-ejfv-with-KEYTRUDA-pembrolizumab-for-the-First-Line-Treatment-of-Certain-Patients-With-Locally-Advanced-or-Metastatic-Urothelial-Cancer/default.aspx

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