Drugs / Enfortumab Vedotin
Regulatory milestones approvals, filings & regulatory actions · 20 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed bladder transitional cell carcinoma 7 milestones | |||||
| Filed | EU (EMA) | PADCEV | bladder transitional cell carcinoma | 2024-01-26 | “the European Medicines Agency (EMA) validated for review a Type II variation application for PADCEV ® (enfortumab vedotin)” astellas.com ↗ “EMA validated for review a Type II variation application for PADCEV ™ (enfortumab vedotin)” astellas.com ↗ |
| Filed | China (NMPA) | — | bladder transitional cell carcinoma | 2023-03-09 | “the China National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for enfortumab vedotin” astellas.com ↗ |
| Filed | US (FDA) | PADCEV | bladder transitional cell carcinoma | 2022-12-20 | “FDA has accepted for Priority Review supplemental Biologics License Applications (sBLAs) for PADCEV ® (enfortumab vedotin-ejfv)” astellas.com ↗ “FDA has accepted for priority review supplemental Biologics License Applications (sBLAs) for PADCEV® (enfortumab vedotin-ejfv)” astellas.com ↗ |
| Filed | EU (EMA) | — | bladder transitional cell carcinoma | 2021-03-26 | “a marketing authorization application (MAA) for enfortumab vedotin was accepted by the European Medicines Agency (EMA)” astellas.com ↗ |
| Filed | Japan (PMDA) | — | bladder transitional cell carcinoma | 2021-03-11 | “submission of a New Drug Application (NDA) to Japan's Ministry of Health, Labour and Welfare (MHLW) for enfortumab vedotin” astellas.com ↗ |
| Filed | US (FDA) | PADCEV | bladder transitional cell carcinoma | 2021-02-18 | “completion of submissions for two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) for PADCEV” astellas.com ↗ “today announced the U.S. Food and Drug Administration (FDA) filed two supplemental Biologics License Application (sBLA) submissions for PADCEV” astellas.com ↗ |
| Filed | US (FDA) | — | bladder transitional cell carcinoma | 2019-07-17 | “today announced submission of a Biologics License Application for accelerated approval to the U.S. Food and Drug Administration for the investigational agent enfortumab vedotin” astellas.com ↗ “FDA has accepted the Biologics License Application (BLA) for the investigational agent enfortumab vedotin” astellas.com ↗ |
| Filed infiltrating bladder urothelial carcinoma 4 milestones | |||||
| Filed | US (FDA) | Imfinzi | infiltrating bladder urothelial carcinoma | 2026-09-25 | “AstraZeneca’s supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab) in combination with enfortumab vedotin (EV) has been accepted and granted Priority...” astrazeneca.com ↗ |
| Filed | US (FDA) | PADCEV | infiltrating bladder urothelial carcinoma | 2026-04-20 | “accepted for Priority Review a supplemental Biologics License Application (sBLA) for perioperative (before and after surgery) PADCEV TM (enfortumab vedotin-ejfv)” astellas.com ↗ “accepted for Priority Review a supplemental Biologics License Application (sBLA) for perioperative (before and after surgery) PADCEV™ (enfortumab vedotin-ejfv)” pfizer.com ↗ |
| Filed | EU (EMA) | PADCEV | infiltrating bladder urothelial carcinoma | 2026-03-22 | “the European Medicines Agency (EMA) has validated for review a Type II Variation Application for PADCEV TM (enfortumab vedotin)” astellas.com ↗ |
| Filed | US (FDA) | PADCEV | infiltrating bladder urothelial carcinoma | 2025-10-21 | “FDA accepted for priority review a supplemental Biologics License Application (sBLA) for PADCEV TM (enfortumab vedotin-ejfv)” astellas.com ↗ |
| Filed infiltrating ureter transitional cell carcinoma 2 milestones | |||||
| Filed | EU (EMA) | PADCEV | infiltrating ureter transitional cell carcinoma | 2024-01-29 | “European Medicines Agency Validates Type II Variation Application for PADCEV ™ (enfortumab vedotin) with KEYTRUDA ® (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer” astellas.com ↗ |
| Filed | US (FDA) | PADCEV | infiltrating ureter transitional cell carcinoma | 2023-11-30 | “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...” merck.com ↗ “the U.S. Food and Drug Administration (FDA) accepted for priority review a supplemental Biologics License Application (sBLA) for PADCEV ®” astellas.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (5) | US (FDA) | PADCEV | — | 2021-07-09 – 2026-07-10 | fda.gov ↗ |
| Approved | EU (EMA) | Padcev | — | 2022-04-13 | europa.eu ↗ |
| Approved | US (FDA) | PADCEV | — | 2019-12-18 | fda.gov ↗ |
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 19 trials | ||||||
| Phase 1 | NCT07217496 | Dec 2026 → Jan 2028 expected | urinary bladder cancer, urothelial carcinoma | ImmunityBio, Inc. | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT05614739 | Jan 2023 → Jun 2027 expected | metastatic neoplasm, ureter neoplasm, urinary bladder neoplasm | Eli Lilly and Company | Recruiting | No outcome recorded |
| Phase 1 | NCT05524545 | Nov 2022 → Jun 2025 | urinary bladder cancer, urothelial carcinoma | ALX Oncology Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04963153 | Jul 2022 → Dec 2026 expected | ureter cancer, urethra cancer, urothelial carcinoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05014139 | Dec 2021 → Sep 2025 | in situ carcinoma, non-invasive bladder urothelial carcinoma | Astellas Pharma Global Development, Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT04878029 | Jul 2021 → Nov 2027 expected | infiltrating bladder urothelial carcinoma | Emory University | Recruiting | No outcome recorded |
| Phase 1 | NCT03070990 | Apr 2017 → Feb 2019 | urothelial carcinoma | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT02091999 | May 2014 → Dec 2022 | urothelial carcinoma | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01409135 | Jul 2011 → Apr 2015 | neoplasm | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1/210 trials · 1 missed | ||||||
| Phase 1/2 | NCT07667335 | Oct 2026 → Jul 2029 expected | infiltrating urothelial carcinoma, urinary bladder carcinoma, urothelial carcinoma | Fred Hutchinson Cancer Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07421700 | Mar 2026 → Dec 2027 expected | urothelial carcinoma | Pfizer | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06470282 | Mar 2025 → Jan 2028 expected | urinary bladder carcinoma | University of California, San Francisco | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06434350 | Oct 2024 → Sep 2027 expected | urinary bladder cancer | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06394570 | Sep 2024 → Sep 2028 expected | urinary bladder cancer | University of Texas Southwestern Medical Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06483334 | Jul 2024 → Mar 2028 expected | urothelial carcinoma | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT06305767 | Mar 2024 → Apr 2027 expected | urinary bladder cancer | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04724018 | May 2021 → Feb 2027 expected | renal pelvis/ureter urothelial carcinoma, urinary bladder cancer | Dana-Farber Cancer Institute | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03869190 | Jun 2019 → Oct 2025 | urinary bladder cancer, urothelial carcinoma | Hoffmann-La Roche | Completed | Missed primary |
| Phase 1/2 | NCT03288545 | Oct 2017 → Feb 2026 | renal pelvis neoplasm, ureter neoplasm, urethra neoplasm, urinary bladder neoplasm +1 | Astellas Pharma Global Development, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 239 trials · 1 met primary | ||||||
| Phase 2 | NCT07863765 | May 2027 → May 2030 expected | medullary thyroid gland carcinoma, nut midline carcinoma, thyroid gland undifferentiated (anaplastic) carcinoma | Northwestern University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07643519 | Dec 2026 → Feb 2029 expected | urothelial carcinoma | University of Florida | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07822373 | Nov 2026 → Nov 2034 expected | infiltrating bladder urothelial carcinoma | University of Utah | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07825753 | Sep 2026 → Sep 2027 expected | breast cancer, pancreatic adenocarcinoma | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07663747 | Sep 2026 → Apr 2031 expected | urinary bladder cancer | The Netherlands Cancer Institute | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07139977 | Jul 2026 → Nov 2027 expected | endometrial cancer | William Bradley | Recruiting | No outcome recorded |
| Phase 2 | NCT07690878 | Jul 2026 → Oct 2027 expected | urinary bladder cancer | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07475806 | Mar 2026 → Nov 2027 expected | urinary bladder carcinoma | Astellas Pharma Global Development, Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT07221942 | Jan 2026 → Sep 2028 expected | urothelial carcinoma | Fox Chase Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06041503 | Jan 2026 → Oct 2027 expected | bladder adenocarcinoma, bladder squamous cell carcinoma, testicular germ cell tumor | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT07183319 | Jan 2026 → Mar 2028 expected | urothelial carcinoma | University of Oklahoma | Recruiting | No outcome recorded |
| Phase 2 | NCT07110038 | Dec 2025 → May 2029 expected | squamous cell carcinoma of penis | Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Recruiting | No outcome recorded |
| Phase 2 | NCT07347314 | Nov 2025 → Sep 2028 expected | small intestine adenocarcinoma | National Cancer Center, Japan | Recruiting | No outcome recorded |
| Phase 2 | NCT07087860 | Aug 2025 → Aug 2028 expected | renal pelvis/ureter urothelial carcinoma, urinary bladder carcinoma | Mayo Clinic | Recruiting | No outcome recorded |
| Phase 2 | NCT06356155 | Jul 2025 → Mar 2028 expected | urothelial carcinoma | University of Michigan Rogel Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06906822 | Jun 2025 → Jun 2027 expected | melanoma | Spanish Melanoma Group | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06302569 | May 2025 → Oct 2027 expected | collecting duct carcinoma, kidney medullary carcinoma | Giuseppe Procopio | Recruiting | No outcome recorded |
| Phase 2 | NCT07647289 | Apr 2025 → Apr 2027 expected | infiltrating bladder urothelial carcinoma | Peking University Third Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06809140 | Apr 2025 → Nov 2027 expected | infiltrating bladder urothelial carcinoma | Matthew Galsky | Recruiting | No outcome recorded |
| Phase 2 | NCT06553885 | Apr 2025 → Sep 2029 expected | colorectal cancer, hepatocellular carcinoma | H. Lee Moffitt Cancer Center and Research Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT06891560 | Mar 2025 → Mar 2027 expected | adenoid cystic carcinoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06311214 | Mar 2025 → Mar 2028 expected | metastatic malignant neoplasm | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT05656235 | Nov 2024 → Jun 2028 expected | bladder transitional cell carcinoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting | No outcome recorded |
| Phase 2 | NCT05775471 | Jun 2024 → Jan 2027 expected | renal pelvis/ureter urothelial carcinoma | Jonsson Comprehensive Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06104618 | Dec 2023 → Jun 2028 expected | squamous cell carcinoma of penis | Mayo Clinic | Recruiting | No outcome recorded |
| Phase 2 | NCT05879653 | Oct 2023 → Sep 2025 overdue | urinary bladder cancer | Kyoto University Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05756569 | Sep 2023 → Dec 2026 expected | bladder squamous cell carcinoma, bladder urachal adenocarcinoma, malignant renal pelvis neoplasm, ureter cancer +1 | Emory University | Recruiting | No outcome recorded |
| Phase 2 | NCT06145308 | Aug 2023 → Jul 2028 expected | salivary gland carcinoma | Peking Union Medical College | Recruiting | No outcome recorded |
| Phase 2 | NCT05915351 | Jun 2023 → Jun 2025 overdue | pancreatic ductal adenocarcinoma | University of Kansas Medical Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05923190 | Jun 2023 → Jul 2028 expected | urothelial carcinoma | Fox Chase Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05868265 | Jun 2023 → Jun 2027 expected | urothelial carcinoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT04754191 | Jun 2022 → Apr 2025 overdue | castration-resistant prostate carcinoma | University of Utah | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05239624 | Jun 2022 → Jun 2027 expected | urothelial carcinoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05097599 | Apr 2022 → Jun 2024 | cancer | Strata Oncology | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04995419 | Jul 2021 → May 2022 | urothelial carcinoma | Astellas Pharma Inc | Completed | Met primary |
| Phase 2 | NCT04225117 | Mar 2020 → Feb 2025 overdue | — | Astellas Pharma Global Development, Inc. | Active not recruiting | Mixed |
| Phase 2 | NCT03606174 | Sep 2018 → Aug 2022 | ureter transitional cell carcinoma, urethra transitional cell carcinoma, urinary bladder cancer | Mirati Therapeutics Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT03547973 | Aug 2018 → Apr 2030 expected | urothelial carcinoma | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03219333 | Oct 2017 → Oct 2020 | renal pelvis neoplasm, ureter neoplasm, urethra neoplasm, urinary bladder neoplasm +1 | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 36 trials · 5 met primary | ||||||
| Phase 3 | NCT07566156 | May 2026 → Mar 2030 expected | urinary bladder neoplasm, urothelial carcinoma | Astellas Pharma Global Development, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT04960709 | Aug 2021 → Mar 2026 overdue | urinary bladder carcinoma | AstraZeneca | Active not recruiting | Met primary |
| Phase 3 | NCT04700124 | Apr 2021 → Oct 2025 overdue | urinary bladder cancer | Merck Sharp & Dohme LLC | Active not recruiting | Met primary |
| Phase 3 | NCT04223856 | Mar 2020 → Aug 2023 overdue | urothelial carcinoma | Astellas Pharma Global Development, Inc. | Active not recruiting | Met primary |
| Phase 3 | NCT03924895 | Jul 2019 → Jun 2025 overdue | urinary bladder carcinoma | Merck Sharp & Dohme LLC | Active not recruiting | Met primary |
| Phase 3 | NCT03474107 | Jun 2018 → Jul 2020 | ureter cancer, urinary bladder cancer, urothelial carcinoma | Astellas Pharma Global Development, Inc. | Completed | Met primary |
| Phase 42 trials | ||||||
| Phase 4 | NCT06862219 | Jun 2025 → Dec 2026 expected | urothelial carcinoma | Astellas Pharma Global Development, Inc. | Recruiting | No outcome recorded |
| Phase 4 | NCT06764095 | Jan 2025 → Jul 2028 expected | bladder transitional cell carcinoma, renal pelvis/ureter urothelial carcinoma | Mayo Clinic | Recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT04136808 | — | urothelial carcinoma | Astellas Pharma Global Development, Inc. | Approved for marketing | No outcome recorded |
| Comparator or background therapy13 trials | ||||||
| Phase 1 | NCT07484022 Background | Jun 2026 → Jun 2027 expected | urothelial carcinoma | Generate Biomedicines | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07232602 Background | Feb 2026 → Jul 2031 expected | urinary bladder cancer | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07287995 Background | Feb 2026 → Jun 2029 expected | — | Astellas Pharma Global Development, Inc. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07157956 Background | Sep 2025 → Aug 2028 expected | neoplasm | Convalife (Shanghai) Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07662863 Comparator | Jul 2026 → Dec 2028 expected | peripheral neuropathy, urinary bladder cancer, urothelial carcinoma | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07374549 Comparator | Jun 2026 → Jun 2028 expected | urothelial carcinoma | CSPC Megalith Biopharmaceutical Co.,Ltd. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06904573 Background | Jan 2025 → Jan 2027 expected | urothelial carcinoma | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 2/3 | NCT07815665 Background | Sep 2026 → Oct 2030 expected | urothelial carcinoma | Summit Therapeutics | Recruiting | No outcome recorded |
| Phase 2/3 | NCT06493552 Comparator | Mar 2025 → Sep 2029 expected | urinary bladder carcinoma, urothelial carcinoma | Vasgene Therapeutics, Inc | Recruiting | No outcome recorded |
| Phase 2/3 | NCT04887870 Background | Jun 2021 → Apr 2025 | cancer of unknown primary site | Mirati Therapeutics Inc. | Completed | No outcome recorded |
| Phase 3 | NCT07346053 Comparator | Nov 2026 → Dec 2030 expected | urinary bladder cancer | Guliz Ozgun | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07218380 Background | Dec 2025 → Oct 2029 expected | metastatic malignant neoplasm, transitional cell carcinoma, urinary bladder cancer | Eli Lilly and Company | Recruiting | No outcome recorded |
| — | NCT07629700 Background | Sep 2026 → Sep 2027 expected | peripheral neuropathy, urothelial carcinoma | University of Florence | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 98
| Date | Issuer | Release |
|---|---|---|
| 2026-10-06 | Astellas Pharma Inc | Results Astellas Highlights Data Advancing Cancer Care and Innovation for Patients with Hard-to-Treat Cancers at ESMO 2026 astellas.com ↗
Enfortumab vedotin plus pembrolizumab presentations include the longest follow-up reported to date in locally advanced or metastatic urothelial cancer, along with analyses across patient subgroups and treatment settings. |
| 2026-09-25 | Alexion Pharmaceuticals, Inc. | Regulatory Perioperative Imfinzi plus neoadjuvant enfortumab vedotin granted Priority Review in the US for patients with muscle-invasive bladder cancer astrazeneca.com ↗ |
| 2026-09-17 | Astellas Pharma Inc | Regulatory PADCEV™ (enfortumab vedotin) in Combination with Keytruda® (pembrolizumab) Receives Positive CHMP Opinion for the Treatment of Adults with Resectable Muscle-Invasive Bladder Cancer astellas.com ↗ |
| 2026-07-12 | Astellas Pharma Inc | Regulatory U.S. FDA Approves PADCEV® plus Keytruda® as Neoadjuvant and Adjuvant Treatment for Muscle-Invasive Bladder Cancer Regardless of Cisplatin Eligibility astellas.com ↗
This now marks the first platinum-free regimen approved for adult patients with MIBC, regardless of cisplatin eligibility. |
| 2026-07-10 | Pfizer | Regulatory U.S. FDA Approves PADCEV® plus Keytruda® as Neoadjuvant and Adjuvant Treatment for Muscle-Invasive Bladder Cancer Regardless of Cisplatin Eligibility pfizer.com ↗ |
| 2026-07-10 | Merck Sharp & Dohme LLC | Regulatory FDA Approves KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Each With Padcev® (enfortumab vedotin-ejfv), as Treatment Before and After Surgery for Adults With Muscle-Invasive Bladder Cancer (MIBC) merck.com ↗
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) approved KEYTRUDA ® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Merck’s anti-PD-1 therapies, each in combination with Padcev ® (enfortumab vedotin-ejfv), as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment for the treatment of adult patients with muscle-invasive bladder cancer (MIBC). |
| 2026-07-06 | Astellas Pharma Inc | Regulatory China’s National Medical Products Administration Accepts Biologics License Application for PADCEV™ (enfortumab vedotin) plus Keytruda® (pembrolizumab) in Muscle-Invasive Bladder Cancer astellas.com ↗ |
| 2026-06-24 | Merck Sharp & Dohme LLC | Regulatory European Commission Approves KEYTRUDA® (pembrolizumab) Plus Padcev® (enfortumab vedotin-ejfv) as First PD-1 Inhibitor Plus Antibody-Drug Conjugate Regimen for Adults With Cisplatin-Ineligible Resectable Muscle-Invasive Bladder Cancer merck.com ↗
This approval, which also covers KEYTRUDA SC ® [known as KEYTRUDA QLEX TM (pembrolizumab and berahyaluronidase alfa-pmph) in the U.S.], makes this combination the first and only PD-1 inhibitor plus ADC regimen available for these patients in the EU. |
| 2026-06-23 | Astellas Pharma Inc | Regulatory European Commission Approves PADCEV™ (enfortumab vedotin) in Combination with Keytruda® (pembrolizumab) as the First and Only Approved Perioperative Treatment Option for Cisplatin-Ineligible Patients with Resectable Muscle-Invasive Bladder Cancer astellas.com ↗
The approval establishes the first and only approved perioperative (neoadjuvant and adjuvant) treatment option for this patient population in the EU. |
| 2026-05-22 | Merck Sharp & Dohme LLC | Regulatory Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) Plus Padcev® (enfortumab vedotin-ejfv) as Perioperative Treatment for Adults With Cisplatin-Ineligible Resectable Muscle-Invasive Bladder Cancer merck.com ↗ |
| 2026-05-21 | Astellas Pharma Inc | Regulatory PADCEV™ (enfortumab vedotin) in Combination with Keytruda® (pembrolizumab) Receives Positive CHMP Opinion for the Treatment of Patients with Resectable Muscle-Invasive Bladder Cancer who are Ineligible for Cisplatin-Based Chemotherapy astellas.com ↗
The positive CHMP opinion is based on results from the Phase 3 EV-303 clinical trial (KEYNOTE-905). |
| 2026-05-14 | AstraZeneca | Results Perioperative Imfinzi plus neoadjuvant EV showed statistically significant and clinically meaningful improvements in event-free survival and overall survival in muscle-invasive bladder cancer in the Phase III VOLGA trial astrazeneca.com ↗ |
| 2026-05-14 | Astellas Pharma Inc | Regulatory Astellas Submits Supplemental New Drug Application in Japan for PADCEV™ (enfortumab vedotin) plus Keytruda® (pembrolizumab) in Cisplatin-Eligible Patients with Muscle-Invasive Bladder Cancer astellas.com ↗
Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced the submission of a Supplemental New Drug Application (sNDA) to Japan's Ministry of Health, Labour and Welfare (MHLW) for PADCEV TM (enfortumab vedotin), a Nectin-4 directed antibody-drug conjugate, in combination with Keytruda ® (pembrolizumab), a PD-1 inhibitor, as neoadjuvant treatment (before surgery), and then continued after radical cystectomy (surgery) as adjuvant treatment (after surgery), for adults with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin-containing chemotherapy. |
| 2026-04-20 | Pfizer | Regulatory U.S. FDA Grants Priority Review to sBLA for PADCEV™ + Keytruda® as Perioperative Treatment for Muscle-Invasive Bladder Cancer Regardless of Cisplatin Eligibility pfizer.com ↗ |
| 2026-04-20 | Merck Sharp & Dohme LLC | Regulatory FDA Grants Priority Review for KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Each with Padcev® (enfortumab vedotin-ejfv), for Cisplatin-Eligible Patients with Muscle-Invasive Bladder Cancer merck.com ↗ |
| 2026-04-20 | Astellas Pharma Inc | Regulatory U.S. FDA Grants Priority Review to sBLA for PADCEV™ + Keytruda® as Perioperative Treatment for Muscle-Invasive Bladder Cancer Regardless of Cisplatin Eligibility astellas.com ↗ |
| 2026-03-22 | Astellas Pharma Inc | Regulatory EMA Validates Type II Variation Application for PADCEV™ (enfortumab vedotin) plus Keytruda ® (pembrolizumab) in Cisplatin-Eligible Patients with Muscle-Invasive Bladder Cancer astellas.com ↗ |
| 2026-03-01 | Astellas Pharma Inc | Results PADCEV™ + Keytruda ® Cuts Risk of Recurrence or Death by Nearly 50% in Cisplatin-Eligible Muscle-Invasive Bladder Cancer astellas.com ↗
In the Phase 3 EV-304 trial, statistically significant improvements in overall survival and pathological complete response were also observed, with over half of patients having no detectable disease at surgery |
| 2026-02-27 | Pfizer | Results PADCEV™ + Keytruda® Cuts Risk of Recurrence or Death by Nearly 50% in Cisplatin-Eligible Muscle-Invasive Bladder Cancer pfizer.com ↗
An estimated 79.4% of patients were event-free at two years, relative to 66.2% treated with standard of care neoadjuvant chemotherapy. |
| 2026-02-27 | Merck Sharp & Dohme LLC | Results KEYTRUDA® (pembrolizumab) Plus Padcev® (enfortumab vedotin-ejfv) Reduced Risk of Event-Free Survival Events by 47% and Risk of Death by 35% for Cisplatin-Eligible Patients with Muscle-Invasive Bladder Cancer When Given Before and After Surgery merck.com ↗
Median EFS was not reached (NR) (95% CI, NR-NR) for the KEYTRUDA plus Padcev regimen versus 48.5 months (95% CI, 43.3-NR) for neoadjuvant chemotherapy and surgery. |
| 2026-02-12 | Merck Sharp & Dohme LLC | Results Merck Advances Treatment of Bladder and Kidney Cancers with New Data at 2026 ASCO GU Cancers Symposium merck.com ↗
Late-breaking KEYNOTE-B15 data show KEYTRUDA ® (pembrolizumab) plus Padcev ® (enfortumab vedotin-ejfv) significantly improved event-free survival, overall survival and pathologic complete response rates for patients with certain types of bladder cancer |
| 2026-01-30 | Astellas Pharma Inc | Regulatory Astellas Submits Supplemental New Drug Application in Japan for PADCEV™ (enfortumab vedotin) with Keytruda ® (pembrolizumab) for Certain Patients with Muscle-Invasive Bladder Cancer astellas.com ↗ |
| 2025-12-17 | Pfizer | Results PADCEV™ Plus Keytruda® Significantly Improves Survival for Patients with Muscle-Invasive Bladder Cancer Regardless of Cisplatin Eligibility pfizer.com ↗
The trial met its primary endpoint, demonstrating clinically meaningful and statistically significant improvements in event-free survival (EFS), and overall survival (OS), a key secondary endpoint. |
| 2025-12-17 | Merck Sharp & Dohme LLC | Results KEYTRUDA® (pembrolizumab) Plus Padcev® (enfortumab vedotin-ejfv) Significantly Improved Event-Free Survival, Overall Survival and Pathologic Complete Response Rates for Cisplatin-Eligible Patients with MIBC When Given Before and After Surgery merck.com ↗
The strength of these data demonstrates that pembrolizumab plus enfortumab vedotin—given before and after surgery—has the potential to significantly improve survival outcomes. |
| 2025-12-17 | Astellas Pharma Inc | Results PADCEV™ Plus Keytruda ® Significantly Improves Survival for Patients with Muscle-Invasive Bladder Cancer Regardless of Cisplatin Eligibility astellas.com ↗
The trial met its primary endpoint, demonstrating clinically meaningful and statistically significant improvements in event-free survival (EFS), and overall survival (OS), a key secondary endpoint. |
| 2025-11-30 | Astellas Pharma Inc | Regulatory European Medicines Agency Validates Type II Variation Application for PADCEV TM (enfortumab vedotin) with KEYTRUDA TM (pembrolizumab) for Certain Patients with Muscle-Invasive Bladder Cancer astellas.com ↗ |
| 2025-11-24 | Astellas Pharma Inc | Regulatory U.S. FDA Approves PADCEV ® plus Keytruda ® for Certain Patients with Bladder Cancer astellas.com ↗ |
| 2025-11-21 | Pfizer | Regulatory U.S. FDA Approves PADCEV® plus Keytruda® for Certain Patients with Bladder Cancer pfizer.com ↗
PADCEV plus Keytruda is the first and only approved perioperative treatment regimen that can significantly improve survival over current standard of care (surgery alone) in cisplatin-ineligible patients with muscle-invasive bladder cancer |
| 2025-11-21 | Merck Sharp & Dohme LLC | Regulatory FDA Approves KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Each with Padcev® (enfortumab vedotin-ejfv), as Perioperative Treatment for Adults with Cisplatin-Ineligible Muscle-Invasive Bladder Cancer merck.com ↗
These approvals represent the first PD-1 inhibitor plus ADC regimens for this patient population. |
| 2025-10-23 | Merck Sharp & Dohme LLC | Regulatory FDA Grants Priority Review for KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Each in Combination with Padcev® (enfortumab vedotin-ejfv), for Certain Patients with Muscle-Invasive Bladder Cancer merck.com ↗ |
| 2025-10-21 | Astellas Pharma Inc | Regulatory PADCEV™ (enfortumab vedotin-ejfv) Plus KEYTRUDA ® (pembrolizumab) sBLA Granted FDA Priority Review for Treatment of Certain Patients with Muscle-Invasive Bladder Cancer astellas.com ↗
Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the U.S. Food and Drug Administration (FDA) accepted for priority review a supplemental Biologics License Application (sBLA) for PADCEV TM (enfortumab vedotin-ejfv) in combination with KEYTRUDA ® (pembrolizumab) as a neoadjuvant treatment (before surgery) and then continued after radical cystectomy as adjuvant treatment (after surgery) for patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy. |
| 2025-10-19 | Astellas Pharma Inc | Results PADCEV™ Plus KEYTRUDA™, Given Before and After Surgery, Cuts the Risk of Recurrence, Progression or Death by 60% and the Risk of Death by 50% for Certain Patients with Bladder Cancer astellas.com ↗
PADCEV plus KEYTRUDA significantly improved event-free survival (EFS) and overall survival (OS) when used as a neoadjuvant and adjuvant treatment (before and after surgery) versus the current standard of care—surgery alone. |
| 2025-10-18 | Pfizer | Results PADCEV™ Plus KEYTRUDA™, Given Before and After Surgery, Cuts the Risk of Recurrence, Progression or Death by 60% and the Risk of Death by 50% for Certain Patients with Bladder Cancer pfizer.com ↗
PADCEV plus KEYTRUDA significantly improved event-free survival (EFS) and overall survival (OS) when used as a neoadjuvant and adjuvant treatment (before and after surgery) versus the current standard of care—surgery alone. |
| 2025-10-18 | Merck Sharp & Dohme LLC | Results KEYTRUDA® (pembrolizumab) Plus Padcev® (enfortumab vedotin-ejfv) Reduced Risk of Event-Free Survival Events by 60% and Risk of Death by 50% for Certain Patients with Muscle-Invasive Bladder Cancer When Given Before and After Surgery merck.com ↗ |
| 2025-08-12 | Pfizer | Results PADCEV™ Plus KEYTRUDA™ Significantly Improves Survival for Certain Patients with Bladder Cancer When Given Before and After Surgery pfizer.com ↗
Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced positive topline results from the Phase 3 EV-303 clinical trial (also known as KEYNOTE-905). |
| 2025-08-12 | Merck Sharp & Dohme LLC | Results KEYTRUDA® (pembrolizumab) plus Padcev® (enfortumab vedotin-ejfv) Significantly Improved Event-Free and Overall Survival and Pathologic Complete Response Rate for Certain Patients with Muscle-Invasive Bladder Cancer When Given Before and After Surgery merck.com ↗ |
| 2025-08-12 | Astellas Pharma Inc | Results PADCEV TM Plus KEYTRUDA TM Significantly Improves Survival for Certain Patients with Bladder Cancer When Given Before and After Surgery astellas.com ↗
An additional secondary endpoint of pathologic complete response (pCR) rate was also met. |
| 2025-02-12 | Astellas Pharma Inc | Results Pfizer and Astellas’ PADCEV ® (enfortumab vedotin-ejfv) plus KEYTRUDA ® (pembrolizumab) Shows Long-Term Efficacy in First Line Treatment of Locally Advanced or Metastatic Urothelial Cancer (la/mUC) astellas.com ↗
The results showed a sustained overall survival (OS) and progression-free survival (PFS) benefit consistent with the findings of the primary analysis after an additional 12 months of follow-up (median follow-up of 29.1 months). |
| 2025-02-10 | Pfizer | Results Pfizer and Astellas’ PADCEV® (enfortumab vedotin-ejfv) plus KEYTRUDA® (pembrolizumab) Shows Long-Term Efficacy in First-Line Treatment of Locally Advanced or Metastatic Urothelial Cancer (la/mUC) pfizer.com ↗
The results showed a sustained overall survival (OS) and progression-free survival (PFS) benefit consistent with the findings of the primary analysis after an additional 12 months of follow-up (median follow-up of 29.1 months). |
| 2025-01-28 | Pfizer | Results Pfizer to Showcase Advancements Across Genitourinary Cancers at ASCO GU Cancers Symposium pfizer.com ↗
Updated analysis from the Phase 3 EV-302 trial highlights sustained OS benefit of PADCEV ® in combination with pembrolizumab in locally advanced or metastatic urothelial cancer |
| 2025-01-08 | Astellas Pharma Inc | Regulatory China’s National Medical Products Administration (NMPA) Approves PADCEV TM in combination with KEYTRUDA ® (pembrolizumab) for the Treatment of Advanced Bladder Cancer astellas.com ↗
Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, “Astellas”) today announced that China’s National Medical Products Administration (NMPA) has approved PADCEV TM (enfortumab vedotin) in combination with KEYTRUDA ® (pembrolizumab) for adult patients with locally advanced or metastatic urothelial cancer (la/mUC). |
| 2024-09-25 | Merck Sharp & Dohme LLC | Regulatory Merck’s KEYTRUDA® (pembrolizumab) Receives New Approvals in Japan for Certain Patients With Non-Small Cell Lung Carcinoma (NSCLC) and Radically Unresectable Urothelial Carcinoma merck.com ↗
KEYTRUDA in combination with Padcev (enfortumab vedotin-ejfv) for the first-line treatment of patients with radically unresectable urothelial carcinoma based on results from the Phase 3 KEYNOTE-A39 trial (also known as EV-302), which was conducted in a research collaboration with Pfizer (previously Seagen) and Astellas; |
| 2024-09-24 | Astellas Pharma Inc | Regulatory Japan’s Ministry of Health, Labour and Welfare Approves PADCEV TM (enfortumab vedotin) with KEYTRUDA ® (pembrolizumab) for First-Line Treatment of Radically Unresectable Urothelial Carcinoma astellas.com ↗
Today’s approval by Japan’s MHLW expands the benefits of treatment with enfortumab vedotin in combination with pembrolizumab to patients living with radically unresectable urothelial carcinoma in Japan. |
| 2024-09-11 | Astellas Pharma Inc | Results Astellas Presents Scientific Progress in Advanced and Hard-to-Treat Cancers at ESMO 2024 astellas.com ↗
These results support the combination as a first-line advancement across la/mUC patient subgroups, regardless of Nectin-4 expression. |
| 2024-09-03 | Merck Sharp & Dohme LLC | Regulatory European Commission Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Padcev® (enfortumab vedotin-ejfv) as First-Line Treatment of Unresectable or Metastatic Urothelial Carcinoma in Adults merck.com ↗ |
| 2024-08-28 | Astellas Pharma Inc | Regulatory European Commission Approves Astellas’ PADCEV TM (enfortumab vedotin) in Combination with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Advanced Urothelial Cancer astellas.com ↗ |
| 2024-08-20 | Astellas Pharma Inc | Regulatory China’s National Medical Products Administration (NMPA) Approves PADCEV TM (enfortumab vedotin) for Treatment of Locally Advanced or Metastatic Urothelial Cancer astellas.com ↗
On August 13, 2024, the NMPA officially approved the use of enfortumab vedotin for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (la/mUC) after prior treatment with platinum-containing chemotherapy and PD-1/PD-L1 inhibitors. |
| 2024-07-29 | Astellas Pharma Inc | Regulatory Astellas Receives Positive CHMP Opinion for PADCEV TM (enfortumab vedotin) in combination with KEYTRUDA ® (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer astellas.com ↗
The positive CHMP opinion is based on data from the Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39) which showed enfortumab vedotin in combination with pembrolizumab significantly extends overall survival (OS) and progression-free survival (PFS) compared to platinum-containing chemotherapy in patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC). |
| 2024-07-26 | Merck Sharp & Dohme LLC | Regulatory Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) Plus Padcev® (enfortumab vedotin-ejfv) as First-Line Treatment for Patients With Unresectable or Metastatic Urothelial Carcinoma merck.com ↗
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv), an antibody-drug conjugate, for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma. |
| 2024-03-28 | Astellas Pharma Inc | Regulatory China’s National Medical Products Administration Accepts Astellas and Pfizer’s Supplemental Biologics License Application for enfortumab vedotin with KEYTRUDA ® (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer astellas.com ↗
The CDE’s acceptance of our sBLA for enfortumab vedotin and pembrolizumab brings us one step closer to delivering a much-needed, innovative new treatment option for this patient population. |
| 2024-02-15 | Astellas Pharma Inc | Regulatory PADCEV TM (enfortumab vedotin (genetical recombination)) with KEYTRUDA ® (pembrolizumab (genetical recombination)) Granted Priority Review by Japan’s Ministry of Health, Labour and Welfare for First-Line Treatment of Advanced Bladder Cancer astellas.com ↗
The MHLW’s priority review for our application for PADCEV in combination with pembrolizumab reflects the significance of the EV-302 trial findings and the urgent need for innovative new treatment options. |
| 2024-01-31 | Astellas Pharma Inc | Regulatory Astellas Submits Supplemental New Drug Application in Japan for PADCEV TM (enfortumab vedotin (genetical recombination) with KEYTRUDA ® (pembrolizumab (genetical recombination)) for First-Line Treatment of Advanced Bladder Cancer astellas.com ↗
This submission brings us one step closer to the possibility of offering these patients a treatment that demonstrated improved survival and slowed disease progression compared to platinum-containing chemotherapy. |
| 2024-01-26 | Pfizer | Regulatory European Medicines Agency Validates Type II Variation Application for PADCEV® (enfortumab vedotin) with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer pfizer.com ↗ |
| 2024-01-26 | Astellas Pharma Inc | Regulatory European Medicines Agency Validates Type II Variation Application for PADCEV TM (enfortumab vedotin) with KEYTRUDA ® (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer astellas.com ↗ |
| 2023-12-15 | Pfizer | Regulatory PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) Approved by FDA as the First and Only ADC Plus PD-1 to Treat Advanced Bladder Cancer pfizer.com ↗ |
| 2023-12-15 | Merck Sharp & Dohme LLC | Regulatory FDA Approves Expanded Indication for KEYTRUDA® (pembrolizumab) Plus Padcev® (enfortumab vedotin-ejfv) for the First-Line Treatment of Adult Patients With Locally Advanced or Metastatic Urothelial Cancer merck.com ↗
Approval expands the use of KEYTRUDA plus Padcev for locally advanced or metastatic urothelial cancer regardless of cisplatin eligibility |
| 2023-12-15 | Astellas Pharma Inc | Regulatory PADCEV ® (enfortumab vedotin-ejfv) with KEYTRUDA ® (pembrolizumab) Approved by FDA as the First and Only ADC Plus PD-1 to Treat Advanced Bladder Cancer astellas.com ↗
This combination is the first approved to offer an alternative to platinum-containing chemotherapy, the current standard of care in first-line la/mUC. |
| 2023-11-30 | Merck Sharp & Dohme LLC | Regulatory FDA Grants Priority Review to Merck’s Application for KEYTRUDA® (pembrolizumab) Plus Padcev® (enfortumab vedotin-ejfv) for the First-Line Treatment of Patients With Locally Advanced or Metastatic Urothelial Cancer merck.com ↗ |
| 2023-11-30 | Astellas Pharma Inc | Regulatory FDA Grants Priority Review for Supplemental Biologics License Application (sBLA) of PADCEV ® (enfortumab vedotin-ejfv) with KEYTRUDA ® (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer astellas.com ↗
FDA Grants Priority Review for Supplemental Biologics License Application (sBLA) of PADCEV ® (enfortumab vedotin-ejfv) with KEYTRUDA ® (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer |
| 2023-10-22 | Merck Sharp & Dohme LLC | Results KEYTRUDA® (pembrolizumab) Plus Padcev® (enfortumab vedotin-ejfv) Reduced Risk of Death by More Than Half Versus Chemotherapy in Patients With Previously Untreated Locally Advanced or Metastatic Urothelial Cancer merck.com ↗
KEYTRUDA plus enfortumab vedotin significantly prolonged overall survival (OS) by 53% – an improvement in median OS of more than 15 months – compared to chemotherapy in the total patient population |
| 2023-10-22 | Astellas Pharma Inc | Results Groundbreaking EV-302 Trial Significantly Extends Overall Survival and Progression-Free Survival in Patients Treated with PADCEV ® (enfortumab vedotin-ejfv) and KEYTRUDA ® (pembrolizumab) in First-Line Advanced Bladder Cancer astellas.com ↗
The combination improved overall survival (OS) and progression-free survival (PFS) with statistically significant and clinically meaningful results in patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC). |
| 2023-10-10 | Merck Sharp & Dohme LLC | Results Merck Highlights Innovative Oncology Portfolio and Pipeline at ESMO Congress 2023 Underscoring Commitment to Advancing Cancer Research and Improving Patient Outcomes Across Multiple Stages of Disease merck.com ↗
First Phase 3 survival data from KEYNOTE-A39/EV-302 support potential benefit of combination approach in previously untreated locally advanced or metastatic urothelial cancer; data are selected for ESMO Presidential Symposium Session and official Press Briefings |
| 2023-09-22 | Merck Sharp & Dohme LLC | Results Merck Announces Phase 3 KEYNOTE-A39/EV-302 Trial Met Dual Primary Endpoints of Overall Survival (OS) and Progression-Free Survival (PFS) in Certain Patients With Previously Untreated Locally Advanced or Metastatic Urothelial Cancer merck.com ↗
In the trial, KEYTRUDA in combination with enfortumab vedotin met its dual primary endpoints of overall survival (OS) and progression-free survival (PFS), demonstrating a statistically significant and clinically meaningful improvement versus chemotherapy in patients with previously untreated la/mUC. |
| 2023-09-22 | Astellas Pharma Inc | Results PADCEV ® (enfortumab vedotin-ejfv) and KEYTRUDA ® (pembrolizumab) Significantly Improve Overall Survival and Progression-Free Survival in Patients With Previously Untreated Advanced Bladder Cancer in Pivotal Phase 3 EV-302 Trial astellas.com ↗
The EV-302 study met its dual primary endpoints of overall survival (OS) and progression-free survival (PFS), compared to chemotherapy. |
| 2023-04-03 | Merck Sharp & Dohme LLC | Regulatory FDA Approves Merck’s KEYTRUDA® (pembrolizumab) in Combination With Padcev® (enfortumab vedotin-ejfv) for First-Line Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer merck.com ↗
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (la/mUC) who are not eligible for cisplatin-containing chemotherapy. |
| 2023-04-03 | Astellas Pharma Inc | Regulatory FDA Grants Accelerated Approval for PADCEV ® (enfortumab vedotin-ejfv) with KEYTRUDA ® (pembrolizumab) for First-Line Treatment of Locally Advanced or Metastatic Urothelial Cancer astellas.com ↗
This indication is approved under accelerated approval based on tumor response rate and durability of response. |
| 2023-03-09 | Astellas Pharma Inc | Regulatory Astellas and Seagen Announce China’s National Medical Products Administration Accepts Biologics License Application for Enfortumab Vedotin in Certain Patients with Locally Advanced or Metastatic Urothelial Cancer astellas.com ↗
Astellas and Seagen Announce China’s National Medical Products Administration Accepts Biologics License Application for Enfortumab Vedotin in Certain Patients with Locally Advanced or Metastatic Urothelial Cancer |
| 2022-12-20 | Merck Sharp & Dohme LLC | Regulatory Astellas, Seagen and Merck Announce FDA Acceptance of Supplemental Biologics License Applications for PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) for the First-Line Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer merck.com ↗
FDA granted the applications priority review with a PDUFA date of April 21, 2023 |
| 2022-12-20 | Astellas Pharma Inc | Regulatory Astellas, Seagen and Merck Announce FDA Acceptance of sBLA for PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) for the First-Line Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer astellas.com ↗ |
| 2022-09-12 | Merck Sharp & Dohme LLC | Results Seagen, Astellas and Merck Announce Results of Clinical Trial Investigating PADCEV® (enfortumab vedotin-ejfv) With KEYTRUDA® (pembrolizumab) and PADCEV as Monotherapy in First-Line Advanced Urothelial Cancer merck.com ↗
Results demonstrated a 64.5% confirmed objective response rate in patients treated with investigational combination of enfortumab vedotin and pembrolizumab |
| 2022-09-12 | Astellas Pharma Inc | Results Astellas, Seagen and Merck Announce Results of Clinical Trial Investigating PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) and PADCEV as Monotherapy in First-Line Advanced Urothelial Cancer astellas.com ↗
The median duration of response (DOR) per BICR was not reached (95% CI: 10.25 months to NR). |
| 2022-07-26 | Astellas Pharma Inc | Results Astellas and Seagen Announce Positive Topline Results For PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) as First-Line Treatment for Advanced Urothelial Cancer astellas.com ↗
In patients treated with enfortumab vedotin and pembrolizumab, results demonstrated a 64.5% confirmed objective response rate (ORR) (95% CI: 52.7 to 75.1) per blinded independent central review (BICR), the primary endpoint of Cohort K. |
| 2022-04-13 | Astellas Pharma Inc | Regulatory European Commission Approves PADCEV™ (enfortumab vedotin) for Locally Advanced or Metastatic Urothelial Cancer astellas.com ↗ |
| 2022-02-28 | Astellas Pharma Inc | Regulatory Astellas and Seagen Announce CHMP Confirms Positive Opinion for PADCEV™ (enfortumab vedotin) in Locally Advanced or Metastatic Urothelial Cancer astellas.com ↗
Following a request from the EC and taking into account the latest information, the CHMP re-adopted its positive opinion. |
| 2022-02-14 | Astellas Pharma Inc | Results Astellas and Seagen Announce Initial Results of PADCEV® (enfortumab vedotin-ejfv) in Patients with Muscle-Invasive Bladder Cancer Not Eligible for Cisplatin Chemotherapy astellas.com ↗
Results from the preliminary analysis of 22 patients showed 36.4% had a pathologic complete response, the primary endpoint, displaying no signs of cancer upon microscopic examination of tissue cells removed during surgery. |
| 2021-12-18 | Astellas Pharma Inc | Regulatory FDA Grants Accelerated Approval to Astellas’ and Seattle Genetics’ PADCEV™ (enfortumab vedotin-ejfv) for People with Locally Advanced or Metastatic Urothelial Cancer, the Most Common Type of Bladder Cancer astellas.com ↗
PADCEV is approved under the FDA’s Accelerated Approval Program based on tumor response rate. |
| 2021-12-17 | Astellas Pharma Inc | Regulatory Astellas and Seagen Receive Positive CHMP Opinion for PADCEV™ (enfortumab vedotin) in Locally Advanced or Metastatic Urothelial Cancer astellas.com ↗
The positive opinion from the CHMP will now be reviewed by the EC. |
| 2021-09-27 | Astellas Pharma Inc | Regulatory Japan’s MHLW Approves PADCEV® (enfortumab vedotin) for Advanced Urothelial Cancer astellas.com ↗
Astellas Pharma Inc. (TSE:4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Seagen Inc. (Nasdaq:SGEN) today announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved PADCEV ® (enfortumab vedotin) for radically unresectable urothelial carcinoma that has progressed after anti-cancer chemotherapy. |
| 2021-07-09 | Astellas Pharma Inc | Regulatory U.S. FDA Grants Regular Approval and Expands Indication for PADCEV® (enfortumab vedotin-ejfv) for Patients with Locally Advanced or Metastatic Urothelial Cancer astellas.com ↗
The FDA’s decision to convert accelerated approval to regular approval was based on data from the Phase 3 EV-301 trial, which had a primary endpoint of overall survival for patients treated with PADCEV versus chemotherapy |
| 2021-05-19 | Astellas Pharma Inc | Results Astellas and Seagen Announce Updated Results from Two Trials of PADCEV® (enfortumab vedotin-ejfv) in Patients with Locally Advanced or Metastatic Urothelial Cancer Not Eligible for Cisplatin Chemotherapy astellas.com ↗
The analysis that will be presented at ASCO showed that after a median follow-up of 16 months, many patients continued to benefit from PADCEV – an important finding for these patients, who have very limited treatment options. |
| 2021-05-14 | Astellas Pharma Inc | Regulatory Japan’s Ministry of Health, Labour and Welfare Grants Priority Review for Enfortumab Vedotin New Drug Application astellas.com ↗
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced Japan's Ministry of Health, Labour and Welfare (MHLW) has granted priority review for the company’s New Drug Application (NDA), which was submitted in March. |
| 2021-04-19 | Astellas Pharma Inc | Regulatory Astellas and Seagen Announce U.S. FDA Acceptance of Two Supplemental Biologics License Applications for PADCEV® (enfortumab vedotin-ejfv) in Locally Advanced or Metastatic Urothelial Cancer astellas.com ↗
The applications were granted Priority Review, with a target action date of August 17, 2021. |
| 2021-03-26 | Astellas Pharma Inc | Regulatory European Medicines Agency Accepts Marketing Authorization Application for Enfortumab Vedotin astellas.com ↗
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Seagen Inc. (Nasdaq:SGEN) today announced that a marketing authorization application (MAA) for enfortumab vedotin was accepted by the European Medicines Agency (EMA). |
| 2021-03-11 | Astellas Pharma Inc | Regulatory Astellas Submits New Drug Application for Enfortumab Vedotin in Japan astellas.com ↗
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced the submission of a New Drug Application (NDA) to Japan's Ministry of Health, Labour and Welfare (MHLW) for enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer that has progressed after anti-cancer medication. |
| 2021-02-18 | Astellas Pharma Inc | Regulatory Astellas and Seagen Announce Submission of Two Supplemental Biologics License Applications to the U.S. FDA for PADCEV® (enfortumab vedotin-ejfv) in Locally Advanced or Metastatic Urothelial Cancer astellas.com ↗
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Seagen Inc. (Nasdaq:SGEN) today announced completion of submissions for two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) for PADCEV ® (enfortumab vedotin-ejfv). |
| 2021-02-12 | Astellas Pharma Inc | Results Astellas and Seagen Announce Presentation of Results from PADCEV® (enfortumab vedotin-ejfv) Pivotal Trial in Patients with Previously Treated Advanced Urothelial Cancer Who Were Ineligible for Cisplatin Chemotherapy astellas.com ↗
In the trial, 52 percent of patients who received PADCEV ® (enfortumab vedotin-ejfv) had an objective response (95 percent Confidence Interval [CI]: 40.8, 62.4) and the median duration of response was 10.9 months (95 percent CI: 5.8, NR). |
| 2021-02-12 | Astellas Pharma Inc | Results Astellas and Seagen Announce Phase 3 Trial Results Demonstrating Survival Advantage of PADCEV® (enfortumab vedotin-ejfv) in Patients with Previously Treated Advanced Urothelial Cancer astellas.com ↗
At the time of pre-specified interim analysis, patients who received PADCEV in the trial lived a median of 3.9 months longer than those who received chemotherapy. |
| 2020-10-12 | Astellas Pharma Inc | Results Astellas and Seagen Announce Positive Topline Results from Second Cohort of Patients in Phase 2 Pivotal Trial of PADCEV® (enfortumab vedotin-ejfv) in Advanced Urothelial Cancer astellas.com ↗ |
| 2020-09-18 | Astellas Pharma Inc | Results Astellas and Seattle Genetics Announce PADCEV® (enfortumab vedotin-ejfv) Significantly Improved Overall Survival in Phase 3 Trial in Previously Treated Locally Advanced or Metastatic Urothelial Cancer astellas.com ↗
In the trial, PADCEV significantly improved overall survival (OS), with a 30 percent reduction in risk of death (Hazard Ratio [HR]=0.70; [95% Confidence Interval (CI): 0.56, 0.89]; p=0.001). |
| 2020-02-19 | Astellas Pharma Inc | Regulatory Astellas and Seattle Genetics Receive FDA Breakthrough Therapy Designation for PADCEV™ (enfortumab vedotin-ejfv) in Combination with Pembrolizumab in First-Line Advanced Bladder Cancer astellas.com ↗
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Seattle Genetics, Inc. (Nasdaq:SGEN) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for PADCEV™ (enfortumab vedotin-ejfv) in combination with Merck’s (known as MSD outside the United States and Canada) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) for the treatment of patients with unresectable locally advanced or metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy in the first-line setting. |
| 2020-02-10 | Astellas Pharma Inc | Results Seattle Genetics and Astellas Announce Updated Results from Phase 1b/2 Trial of PADCEV™ (enfortumab vedotin-ejfv) in Combination with Immune Therapy Pembrolizumab as Investigational First-Line Treatment for Advanced Bladder Cancer astellas.com ↗
Seattle Genetics, Inc. (Nasdaq:SGEN) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced updated results from the phase 1b/2 clinical trial EV-103 in previously untreated patients with locally advanced or metastatic urothelial cancer who were ineligible for treatment with cisplatin-based chemotherapy. |
| 2019-09-30 | Astellas Pharma Inc | Results Seattle Genetics and Astellas Announce Results from Phase 1 Trial of Investigational Agent Enfortumab Vedotin in Combination with Immune Therapy Pembrolizumab as First-Line Treatment for Advanced Bladder Cancer astellas.com ↗
The data demonstrated the combination of enfortumab vedotin plus pembrolizumab shrank tumors in the majority of patients, resulting in a confirmed objective response rate (ORR) of 71 percent (32/45; 95% Confidence Interval (CI): 55.7, 83.6). |
| 2019-09-17 | Astellas Pharma Inc | Regulatory Seattle Genetics and Astellas Announce US FDA Grants Priority Review for Enfortumab Vedotin Biologics License Application in Locally Advanced or Metastatic Urothelial Cancer astellas.com ↗
Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of March 15, 2020. |
| 2019-07-17 | Astellas Pharma Inc | Regulatory Astellas and Seattle Genetics Announce Submission of Biologics License Application to FDA for Enfortumab Vedotin for Patients with Locally Advanced or Metastatic Urothelial Cancer astellas.com ↗
Astellas and Seattle Genetics Announce Submission of Biologics License Application to FDA for Enfortumab Vedotin for Patients with Locally Advanced or Metastatic Urothelial Cancer |
| 2019-06-04 | Astellas Pharma Inc | Results Astellas and Seattle Genetics Announce Antibody-Drug Conjugate Enfortumab Vedotin Produced Tumor Response Rate of 44 Percent in Patients with Most Common Type of Advanced Urothelial (Bladder) Cancer astellas.com ↗
Complete responses (CR) were observed in 12 percent of patients (15/125). |
| 2019-03-28 | Astellas Pharma Inc | Results Seattle Genetics and Astellas Announce Positive Topline Results from Pivotal Trial of Enfortumab Vedotin in Locally Advanced or Metastatic Urothelial Cancer - Companies Plan to Submit Biologics License Application Later This Year – astellas.com ↗
Results showed a 44 percent objective response rate (ORR) per blinded independent central review. |
| 2018-06-04 | Astellas Pharma Inc | Results Astellas and Seattle Genetics Present at ASCO 2018 on Enfortumab Vedotin in Patients with Locally Advanced or Metastatic Urothelial Cancer Previously Treated with Checkpoint Inhibitor Therapy astellas.com ↗
Data from the ongoing study support the potential of enfortumab vedotin in locally advanced or metastatic urothelial cancer, based on the objective response rate and preliminary estimates of survival. |
| 2018-03-27 | Astellas Pharma Inc | Regulatory Astellas and Seattle Genetics Receive FDA Breakthrough Therapy Designation for Enfortumab Vedotin in Locally Advanced or Metastatic Urothelial Cancer astellas.com ↗
Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, “Astellas”) and Seattle Genetics, Inc. (NASDAQ: SGEN) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to enfortumab vedotin, an antibody-drug conjugate (ADC), for patients with locally advanced or metastatic urothelial cancer who were previously treated with checkpoint inhibitors (CPI). |
All press releases naming this drug 102 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 102 releases opens the full record — a long page | ||
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 82 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Enfortumab Vedotin | “FORAGER-2: A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Vepugratinib Combined With Enfortumab Vedotin and Pembrolizumab...” NCT07218380 ↗76“Based on the PTC results, each participant will receive an individualized neoadjuvant regimen selected from gemcitabine plus cisplatin, disitamab vedotin (RC48), enfortumab...” NCT07690878 ↗ “EV (Enfortumab Vedotin): 1.25 mg/kg administered intravenously on Days 1, 8, and 15 of every 4 weeks.” NCT07662863 ↗ “Arm A: MK-3120 + Enfortumab Vedotin (EV) + Pembrolizumab” NCT07232602 ↗ |
| Known as | ASG-22CE | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05879653 ↗ |
| Known as | ASG-22ME | “Hybridoma (AGS-22M6E) and CHO (ASG-22CE) versions of enfortumab vedotin (also known as ASG-22ME) ADC were able to bind to cell surface-expressed nectin-4 with high affinity and...” PMID 27013195 ↗ Mar 2016 |
| Known as | enfortumab | “Enfortumab vedotin (enfortumab) is an investigational ADC” NCT03606174 ↗ |
| Known as | Enfortumab vedotin-ejfv | “Enfortumab vedotin-ejfv (EV)” NCT04724018 ↗ |
| Known as | Padcev | “CVL006（B006 Injection）、Enfortumab Vedotin（Padcev）” NCT07157956 ↗ |
| Action | Deplete | “Enfortumab attaches to nectin-4 tumor cells in a targeted way and delivers vedotin to kill them.” NCT04878029 ↗ |
| Modality | Monoclonal antibody | “AGS-22M6E and ASG-22CE are fully human monoclonal antibody conjugated to a cytotoxic agent monomethyl auristatin E (MMAE)” NCT01409135 ↗ |
| Route | Intravenous | “IV Infusion” NCT01409135 ↗ |
| Target | NECTIN4 | “a novel antibody-drug conjugate directed against Nectin-4” PMID 40819431 ↗ Jul 2025 |