<div>
                                <figure class="article-image__container">
                                    
                                    
                                    
                                    <img src="https://imageproxy.pbkrs.com/https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2026/04/PT-2-21-04-2026-shutterstock_2481473875-430x241.jpg?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" width="430" height="241" original-src="https://imageproxy.pbkrs.com/https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2026/04/PT-2-21-04-2026-shutterstock_2481473875-430x241.jpg"/>
                                    
                                    <figcaption>The submission was based on Phase III EV-304 trial data. Credit: Pickadook / Shutterstock.com.</figcaption>
                                </figure>
                            </div>
                                        
<p>Pfizer and Astellas have received the US Food and Drug Administration (FDA) acceptance for priority review of their supplemental biologics licence application (sBLA) for perioperative Padcev (enfortumab vedotin-ejfv) combined with the PD-1 inhibitor Keytruda (pembrolizumab) for muscle-invasive bladder cancer (MIBC).</p>



<p>The application aims to allow the use of this combination therapy for all patients with MIBC, regardless of their cisplatin eligibility.</p><div>
<div id="div-gpt-ad-6065588-4"></div>
  
</div><div><div>
                   <div><h3>Go deeper with GlobalData</h3><ul><li><div><figure><img src="/wp-content/themes/goodlife-wp-B2B/assets/img/report.png" alt="ReportsLogo" original-src="/wp-content/themes/goodlife-wp-B2B/assets/img/report.png"/></figure></div><div><div>Reports 
                                                                
                                                                    
                                                                    
                                                                
                                                            </div><h4>LOA and PTSR Model - (Avibactam + Aztreonam) in Bacterial Pneumonia </h4></div> </li><li><div><figure><img src="/wp-content/themes/goodlife-wp-B2B/assets/img/report.png" alt="ReportsLogo" original-src="/wp-content/themes/goodlife-wp-B2B/assets/img/report.png"/></figure></div><div><div>Reports 
                                                                
                                                                    
                                                                    
                                                                
                                                            </div><h4>LOA and PTSR Model - (Avibactam + Aztreonam) in Complicated Intra-A... </h4></div> </li></ul> <div>
                    <h5>
                                                Go deeper with GlobalData
                                            </h5>
                    <p>
                        The gold standard of business intelligence.
                    </p>
                    <p>
                            Find out more
                            
                                
                            
                        
                    </p>
                </div>
                </div></div><section><figure><img src="https://imageproxy.pbkrs.com/https://www.pharmaceutical-technology.com/wp-content/themes/goodlife-wp-B2B/assets/img/globaldata_marketing_solutions_logo.svg?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" original-src="https://imageproxy.pbkrs.com/https://www.pharmaceutical-technology.com/wp-content/themes/goodlife-wp-B2B/assets/img/globaldata_marketing_solutions_logo.svg"/></figure><h4> Discover B2B Marketing That Performs </h4><p>
						Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
					</p><p>
							Find out more </p></section></div>



<p>It could potentially broaden the approved use, which was previously limited to cisplatin-ineligible cases.</p><div id="slot-one"></div><div id="Sgpollsputhere"></div>



<p>The submission was based on data from the Phase III EV-304 clinical trial (KEYNOTE-B15), which studied perioperative enfortumab vedotin and pembrolizumab in patients eligible for cisplatin-based chemotherapy.</p>



<p>Under the Prescription Drug User Fee Act, the FDA has set a target action date of 17 August 2026. The FDA grants priority review to medicines that could offer significant treatment advances or fill gaps where few options exist.</p>



<p>Data from the EV-304 trial showed a 47% decrease in the risk of tumour recurrence, progression or death, and a 35% reduction in death risk when compared to standard neoadjuvant gemcitabine and cisplatin chemotherapy.</p>



<p>The pathological complete response (pCR) rate was 55.8% for the combination versus 32.5% in the chemotherapy arm.</p>



<p>The safety profile for the combination was consistent with prior experience, and no new safety signals were observed. Discussions with other global health authorities for potential regulatory filings are ongoing.</p><div id="slot-two"></div>



<p>Participants received either perioperative enfortumab vedotin and pembrolizumab or neoadjuvant chemotherapy, with curative-intent surgery performed in both groups.</p>



<p>The primary endpoint is event-free survival (EFS), with key secondary endpoints including overall survival (OS) and pCR rate.</p>



<p>Pfizer chief oncology officer Jeff Legos said: “For people with muscle-invasive bladder cancer, surgery is often just the beginning of a long and uncertain journey, with far too many patients seeing their cancer return.</p>



<p>“If approved, perioperative Padcev plus pembrolizumab could meaningfully change that experience, potentially helping patients reduce the risk of recurrence and live longer, regardless of whether they are eligible for cisplatin.”</p>



<p>Earlier this year, Pfizer signed a deal worth up to $530m with US-based vaccine technology company Novavax.</p>
<div id="slot-three"></div><p></p>



<div>
    
</div>

ALPMY

SBIO

<p>Pfizer and Astellas have received FDA priority review for their Padcev combination therapy for muscle-invasive bladder cancer (MIBC), which aims to expand treatment options for all patients, regardless of cisplatin eligibility. The application is based on Phase III EV-304 trial data, showing a 47% reduction in tumor recurrence risk and a 35% decrease in death risk compared to standard chemotherapy. The FDA's target action date is August 17, 2026. If approved, this therapy could significantly improve patient outcomes in MIBC treatment.</p>

- Pfizer and Astellas have submitted a supplemental biologics license application for perioperative Padcev combined with Keytruda for muscle-invasive bladder cancer, seeking to broaden its use to all patients regardless of cisplatin eligibility.  
- The FDA has accepted the application for priority review, with a target action date of August 17, 2026, based on positive Phase III EV-304 trial data showing significant reductions in tumor recurrence and improved survival rates.  
- The safety profile remained consistent with prior experience, and discussions for regulatory filings with global health authorities are ongoing.

Pfizer and Astellas secure FDA priority review for Padcev MIBC combo therapy