Seagen (SGEN) Announces FDA Grants Priority Review for sBLA of PADCEV with KEYTRUDA for First-Line Treatment of Advanced Bladder Cancer

November 30, 2023 5:00 PM EST

Seagen Inc. (Nasdaq: SGEN) and Astellas Pharma Inc. (TSE: 4503) today announced that on November 30, 2023 the U.S. Food and Drug Administration (FDA) accepted for priority review a supplemental Biologics License Application (sBLA) for PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) as a combination therapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC), a form of bladder cancer that has spread to surrounding organs or muscles, or other parts of the body.

Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of May 9, 2024. The FDA is reviewing the application under its Real-Time Oncology Review (RTOR) program, which aims to explore a more efficient review process to ensure that safe and effective treatments are available to patients as early as possible. If approved, this combination would be the first treatment option for cisplatin eligible and ineligible patients.

In the U.S., it is estimated that 82,290 people will be diagnosed with bladder cancer in 2023.i Urothelial cancer accounts for 90% of all bladder cancers and can also be found in the renal pelvis, ureter and urethra.ii Approximately 12% of cases are locally advanced or metastatic urothelial cancer at diagnosis.iii Most la/mUC patients will progress within nine months and long-term survival rates are poor.iv

Roger Dansey, M.D.​, President, Research and Development, Seagen​

“Through our clinical development program, data have consistently shown the impact of combining enfortumab vedotin with pembrolizumab for advanced bladder cancer. The FDA’s acceptance of our application is a critical step in our work as we seek to deliver this combination to more patients who currently have few treatment options at the advanced stage.”

Ahsan Arozullah, M.D., M.P.H., Senior Vice President, Head of Oncology Development, Astellas​

“We look forward to the FDA’s review of this application, which, if approved, will convert the accelerated approval of the combination based on results from the EV-103 study to standard approval for all first-line locally advanced or metastatic urothelial cancer patients, expanding the indication to cisplatin eligible patients. These patients have a critical need for innovative new therapies, as chemotherapy has been the standard of care for over 30 years. We are committed to delivering on our goal of helping patients with advanced urothelial cancer live longer.”

The sBLA for first-line use of the combination is based on results from the Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39). The study found that the combination improved overall survival (OS) and progression-free survival (PFS) with statistically significant and clinically meaningful results in patients with previously untreated la/mUC compared to platinum-containing chemotherapy. The safety results were consistent with those previously reported with this combination, and no new safety issues were identified.

Please see Important Safety Information at the end of this press release, including BOXED WARNING for PADCEV (enfortumab vedotin-ejfv).

In February 2020, PADCEV in combination with KEYTRUDA was granted Breakthrough Therapy designation by the FDA and the EV-103 sBLA received Priority Review designation in December 2022. In April 2023, the FDA granted accelerated approval to the combination for the treatment of adult patients with la/mUC who are not eligible to receive cisplatin-containing chemotherapy based on tumor response rate and durability of response from the EV-103 trial. The EV-302 trial, which is intended to serve as the confirmatory trial for the U.S. accelerated approval and as the basis for global regulatory submissions, is also intended to expand the indication into the cisplatin-eligible patient population.

About EV-302

The EV-302 trial is an open-label, randomized, controlled Phase 3 study, evaluating enfortumab vedotin in combination with pembrolizumab versus chemotherapy in patients with previously untreated la/mUC. The study enrolled 886 patients with previously untreated la/mUC who were eligible for cisplatin- or carboplatin-containing chemotherapy regardless of PD-L1 status. Patients were randomized to receive either enfortumab vedotin in combination with pembrolizumab, or chemotherapy. The dual primary endpoints of this trial are OS and PFS per RECIST v1.1 by blinded independent central review (BICR). Select secondary endpoints include overall response rate (ORR) and duration of response (DOR) per RECIST v1.1 by BICR, and safety.

The EV-302 trial is part of an extensive program evaluating this combination in multiple stages of urothelial cancer and other solid tumors. Findings from EV-302 were presented at the European Society for Medical Oncology (ESMO) Congress 2023 in October 2023.

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