Regulatory milestones approvals, filings & regulatory actions · 8 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (6) | US (FDA) | BAVENCIO | — | 2018-10-19 – 2024-10-11 | fda.gov ↗ |
| Approved | EU (EMA) | Bavencio | — | 2017-09-18 | europa.eu ↗ |
| Approved | US (FDA) | BAVENCIO | — | 2017-03-23 | fda.gov ↗ |
Trials 250 · started per year
Also used as a comparator or background therapy in 20 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT05358938 Background | Jun 2022 → Oct 2024 overdue | cutaneous melanoma, cutaneous neuroendocrine carcinoma, skin squamous cell carcinoma | H. Lee Moffitt Cancer Center and Research Institute | Active not recruiting | No outcome recorded |
| Phase 15 trials | ||||||
| Phase 1 | NCT06302426 Background | Jul 2024 → Oct 2026 expected | neoplasm | Inimmune Corporation | Recruiting | No outcome recorded |
| Phase 1 | NCT04551885 Background | Sep 2020 → Aug 2023 | cancer | Fate Therapeutics | Terminated | No outcome recorded |
| Phase 1 | NCT04387084 Background | Aug 2020 → Aug 2026 overdue | skin cancer | University of Southern California | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04328844 Background | Feb 2020 → Dec 2023 overdue | myelofibrosis, non-Hodgkin lymphoma, non-small cell lung carcinoma, uveal melanoma | iOnctura | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02890368 Background | Sep 2016 → Mar 2020 | breast carcinoma, cutaneous neuroendocrine carcinoma, melanoma, mycosis fungoides +2 | Pfizer | Terminated | No outcome recorded |
| Phase 1/27 trials | ||||||
| Phase 1/2 | NCT06939036 Background | Jul → Dec 2025 | cutaneous neuroendocrine carcinoma, small cell lung carcinoma | Ariceum Therapeutics GmbH | Terminated | No outcome recorded |
| Phase 1/2 | NCT04954599 Background | May 2023 → Feb 2027 expected | cancer of unknown primary site | Maastricht University Medical Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04260802 Background | Sep 2020 → Nov 2025 | cervical cancer, cutaneous neuroendocrine carcinoma, gastric cancer, head and neck squamous cell carcinoma +9 | Ocellaris Pharma, Inc. | Terminated | No outcome recorded |
| Phase 1/2 | NCT03747484 Background | Jul 2019 → Jan 2024 | — | Fred Hutchinson Cancer Center | Terminated | No outcome recorded |
| Phase 1/2 | NCT03387085 Background | Mar 2018 → Sep 2020 | triple-negative breast carcinoma | ImmunityBio, Inc. | Terminated | No outcome recorded |
| Phase 1/2 | NCT03167177 Background | Dec 2017 → Jan 2019 | melanoma | ImmunityBio, Inc. | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT02915523 Comparator | Dec 2016 → Feb 2019 | fallopian tube cancer, malignant epithelial tumor of ovary, peritoneum cancer | Syndax Pharmaceuticals | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT06225596 Comparator | Jan 2024 → Mar 2028 expected | urothelial carcinoma | BicycleTx Limited | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04887831 Background | Jun 2021 → Apr 2023 | bone marrow failure syndrome, neutropenia, urinary bladder cancer, urothelial carcinoma | G1 Therapeutics, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT04571632 Comparator | Sep 2020 → Dec 2023 | non-small cell lung carcinoma | University Hospital Brussels | Unknown | No outcome recorded |
| Phase 2 | NCT03573648 Comparator | Nov 2018 → Sep 2026 expected | breast cancer | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Active not recruiting | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT04510597 Comparator | Mar 2021 → Jul 2033 expected | clear cell renal carcinoma | SWOG Cancer Research Network | Recruiting | No outcome recorded |
| Phase 3 | NCT02625623 Comparator | Dec 2015 → Sep 2017 | gastric cancer, gastroesophageal adenocarcinoma | EMD Serono Research & Development Institute, Inc. | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT06820255 Comparator | Jan 2025 → Jan 2026 overdue | bladder transitional cell carcinoma, renal pelvis/ureter urothelial carcinoma | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Recruiting | No outcome recorded |
Press releases naming this drug 45 releases
| Date | Issuer | Release |
|---|---|---|
| 2021-01-25 | Pfizer | European Commission Approves BAVENCIO® (avelumab) for First-Line Maintenance Treatment of Locally Advanced or Metastatic Urothelial Carcinoma pfizer.com ↗ |
| 2020-12-11 | Pfizer | BAVENCIO® (avelumab) Receives Positive CHMP Opinion for First-Line Maintenance Treatment of Locally Advanced or Metastatic Urothelial Carcinoma pfizer.com ↗ |
| 2020-12-11 | Pfizer | BAVENCIO® (avelumab) Receives Positive CHMP Opinion for First-Line Maintenance Treatment of Locally Advanced or Metastatic Urothelial Carcinoma pfizer.com ↗ |
| 2020-09-18 | Pfizer | BAVENCIO Pivotal Phase III JAVELIN Bladder 100 Results Published in The New England Journal of Medicine pfizer.com ↗ |
| 2020-06-30 | Pfizer | FDA Approves BAVENCIO as First-Line Maintenance Treatment for Patients with Locally Advanced or Metastatic Urothelial Carcinoma pfizer.com ↗ |
| 2020-06-22 | Pfizer | European Medicines Agency Validates Application for BAVENCIO® (avelumab) for First-Line Maintenance Treatment of Locally Advanced or Metastatic Urothelial Carcinoma pfizer.com ↗ |
| 2020-06-22 | Pfizer | European Medicines Agency Validates Application for BAVENCIO® (avelumab) for First-Line Maintenance Treatment of Locally Advanced or Metastatic Urothelial Carcinoma pfizer.com ↗ |
| 2020-01-06 | Pfizer | BAVENCIO Significantly Improved Overall Survival in Patients With Locally Advanced or Metastatic Urothelial Carcinoma pfizer.com ↗ |
| 2019-10-28 | Pfizer | European Commission Approves BAVENCIO® (avelumab) Plus Axitinib Combination for First-Line Treatment of Patients With Advanced Renal Cell Carcinoma pfizer.com ↗ |
| 2019-09-27 | Pfizer | New Data for BAVENCIO® (avelumab) for Advanced Cancers to Be Presented at ESMO 2019 pfizer.com ↗ |
| 2019-09-20 | Pfizer | CHMP Adopts Positive Opinion for BAVENCIO® (avelumab) Plus Axitinib for First-Line Treatment of Patients with Advanced Renal Cell Carcinoma pfizer.com ↗ |
| 2019-05-14 | Pfizer | FDA Approves BAVENCIO® (avelumab) Plus INLYTA® (axitinib) Combination for Patients with Advanced Renal Cell Carcinoma pfizer.com ↗ |
| 2019-03-08 | Pfizer | European Medicines Agency Validates Application for BAVENCIO® (avelumab) Plus INLYTA® (axitinib) for the Treatment of Advanced Renal Cell Carcinoma pfizer.com ↗ |
| 2019-02-16 | Pfizer | Pivotal Phase III Data for BAVENCIO® (avelumab) Plus INLYTA® (axitinib) in Advanced Renal Cell Carcinoma Published in The New England Journal of Medicine pfizer.com ↗ |
| 2019-02-11 | Pfizer | FDA Accepts sBLA and Grants Priority Review for BAVENCIO® (avelumab) Plus INLYTA® (axitinib) for the Treatment of Advanced Renal Cell Carcinoma pfizer.com ↗ |
| 2018-12-21 | Pfizer | Merck KGaA, Darmstadt, Germany, and Pfizer Provide Update on JAVELIN Ovarian 100 Trial of Avelumab in Previously Untreated Advanced Ovarian Cancer pfizer.com ↗ |
| 2018-11-19 | Pfizer | Merck KGaA, Darmstadt, Germany, and Pfizer Provide Update on Avelumab in Platinum-Resistant/Refractory Ovarian Cancer pfizer.com ↗ |
| 2018-10-26 | Daiichi Sankyo | Daiichi Sankyo Announces Clinical Research Collaboration with Merck KGaA, Darmstadt, Germany and Pfizer to Evaluate [Fam-] Trastuzumab Deruxtecan (DS-8201) with Avelumab and a DNA Damage Response Inhibitor in Patients with HER2 Expressing and Mutated Solid Tumors daiichisankyo.com ↗ |
| 2018-09-11 | Pfizer | BAVENCIO® (avelumab) Plus INLYTA® (axitinib) Significantly Improved Progression-Free Survival in Previously Untreated Patients with Advanced Renal Cell Carcinoma in Phase III Study pfizer.com ↗ |
| 2018-06-04 | Pfizer | Two-Year Update of Pivotal JAVELIN Merkel 200 Trial Shows Continued Durable Responses with BAVENCIO® (avelumab) pfizer.com ↗ |
| 2017-12-21 | Pfizer | FDA Grants Breakthrough Therapy Designation for Avelumab in Combination with INLYTA® in Advanced Renal Cell Carcinoma pfizer.com ↗ |
| 2017-09-27 | Pfizer | Bavencio (avelumab) Approved for Merkel Cell Carcinoma in Japan pfizer.com ↗ |
| 2017-09-20 | Pfizer | European Commission Approves Bavencio (avelumab) for Metastatic Merkel Cell Carcinoma pfizer.com ↗ |
| 2017-07-21 | Pfizer | EMA's CHMP Issues Positive Opinion for Avelumab for the Treatment of Metastatic Merkel Cell Carcinoma pfizer.com ↗ |
| 2017-05-17 | Pfizer | Merck KGaA, Darmstadt, Germany, and Pfizer to Present Data Highlighting Potential of Avelumab in Challenging Cancers at ASCO 2017 pfizer.com ↗ |
| 2017-05-09 | Pfizer | FDA Grants Second Approval for BAVENCIO® (avelumab) pfizer.com ↗ |
| 2017-05-09 | Pfizer | FDA Grants BAVENCIO® (avelumab) Approval for a Common Type of Advanced Bladder Cancer pfizer.com ↗ |
| 2017-03-23 | Pfizer | FDA Grants Approval for BAVENCIO® (avelumab), the First Immunotherapy Approved for Metastatic Merkel Cell Carcinoma pfizer.com ↗ |
| 2017-02-28 | Pfizer | FDA Accepts the Biologics License Application for Avelumab for the Treatment of Metastatic Urothelial Carcinoma for Priority Review pfizer.com ↗ |
| 2016-11-29 | Pfizer | FDA Accepts the Biologics License Application for Avelumab for the Treatment of Metastatic Merkel Cell Carcinoma for Priority Review pfizer.com ↗ |
| 2016-10-30 | Pfizer | European Medicines Agency Validates the Marketing Authorization Application for Avelumab for the Treatment of Metastatic Merkel Cell Carcinoma pfizer.com ↗ |
| 2016-07-06 | Pfizer | Merck KGaA, Darmstadt, Germany, and Pfizer Initiate Phase III Trial to Evaluate Avelumab as First-line Treatment for Ovarian Cancer pfizer.com ↗ |
| 2016-06-06 | Pfizer | ASCO 2016: Pivotal Avelumab Study Shows Positive Results in Metastatic Merkel Cell Carcinoma pfizer.com ↗ |
| 2016-05-18 | Pfizer | Merck KGaA, Darmstadt, Germany, and Pfizer to Present Avelumab Data in Seven Different Cancers at ASCO Annual Meeting pfizer.com ↗ |
| 2016-04-05 | Pfizer | Merck and Pfizer Announce First Patient Treated in Phase III Combination Study with Avelumab and INLYTA® in Renal Cell Carcinom pfizer.com ↗ |
| 2016-01-04 | Pfizer | Merck KGaA, Darmstadt, Germany, Pfizer and Syndax Announce Collaboration to Evaluate Combination of Avelumab and Entinostat in Ovarian Cancer pfizer.com ↗ |
| 2015-12-22 | Pfizer | Merck KGaA, Darmstadt, Germany and Pfizer Advance Clinical Development Program with Two Additional Phase III Trials of Avelumab pfizer.com ↗ |
| 2015-12-09 | Pfizer | Merck KGaA, Darmstadt, Germany, and Pfizer Initiate Two Phase III Studies of Investigational Immunotherapy Avelumab in Advanced Gastric and Gastro-esophageal Junction Cancers pfizer.com ↗ |
| 2015-11-24 | Pfizer | Merck KGaA, Darmstadt, Germany, and Pfizer Receive Positive Opinion for Orphan Drug Designation for Avelumab in Merkel Cell Carcinoma from EMA Committee for Orphan Medicinal Products pfizer.com ↗ |
| 2015-11-18 | Pfizer | Merck KGaA, Darmstadt, Germany, and Pfizer Receive FDA Breakthrough Therapy Designation for Avelumab in Metastatic Merkel Cell Carcinoma pfizer.com ↗ |
| 2015-11-04 | Pfizer | Merck KGaA, Darmstadt, Germany, and Pfizer Announce Initiation of Phase III First-Line Trial of Avelumab in Patients with Recurrent or Stage IV Non-Small Cell Lung Cancer pfizer.com ↗ |
| 2015-10-07 | Pfizer | Merck KGaA, Darmstadt, Germany, and Pfizer Announce Investigational Immunotherapy Avelumab Receives FDA Fast Track Designation for Metastatic Merkel Cell Carcinoma pfizer.com ↗ |
| 2015-09-11 | Pfizer | Merck KGaA, Darmstadt, Germany and Pfizer to Present Updates for Avelumab at the European Cancer Congress 2015 pfizer.com ↗ |
| 2015-05-13 | Pfizer | Merck KGaA, Darmstadt, Germany, and Pfizer to Present Data at ASCO for Avelumab, an Investigational Anti-PD-L1 Antibody pfizer.com ↗ |
| 2015-04-20 | Pfizer | Global Strategic Partners Merck KGaA, Darmstadt, Germany, and Pfizer Initiate Phase III Study with Avelumab* in Patients with Stage IIIb/IV Non-Small Cell Lung Cancer pfizer.com ↗ |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 275 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Avelumab | “Standard of Care Drugs (at investigator's discretion) may include: pembrolizumab, nivolumab, cemiplimab, durvalumab, dostarlimab, avelumab, and atezolizumab, or other immune...” NCT07224971 ↗267“We aimed to investigate the activity of sequential transarterial chemoembolisation (TACE) and stereotactic body radiotherapy followed by avelumab (an anti-PD-L1 drug) for...” PMID 36529152 ↗ Dec 2022 “TTI-621 will be given in combination with one of the following programmed death-1 (PD-1) or programmed death-ligand-1 (PD-L1) inhibitors: nivolumab, pembrolizumab, durvalumab,...” NCT02890368 ↗ “therapy with avelumab, cemiplimab, ipilimumab, nivolumab, pembrolizumab or relatlimab, or currently approved standard of care treatment, either alone or in combination” NCT05358938 ↗ “IV infusion of avelumab (10 mg/kg over 1 hour) once every 2 weeks.” NCT02999087 ↗ “Avelumab 10 mg/kg will be administered every two weeks.” NCT04258956 ↗ “PD-L1 inhibiting monoclonal antibody Avelumab” NCT03399071 ↗ “either avelumab, trastuzumab or cetuximab” NCT05069935 ↗ “XL092 + Avelumab Dose-Escalation Cohorts” NCT03845166 ↗ “Immunotherapy: Avelumab (6 cycles)” NCT06686381 ↗ “Avelumab 10 mg/kg IV 1 q 2 weeks” NCT04510597 ↗ “Drug: Avelumab” NCT03854799 ↗ “Drug: Avelumab” NCT03341845 ↗ “Avelumab” NCT04954599 ↗ “avelumab” NCT05429866 ↗ “Avelumab” NCT03647423 ↗ |
| Known as | AVE | “IDH1-vac combined with avelumab (AVE), an immune checkpoint inhibitor (ICI) targeting programmed death-ligand 1 (PD-L1).” PMID 35599302 ↗ May 2022 |
| Known as | BAVENCIO | “The drug in this study is: Avelumab (also known as BAVENCIO®)” NCT03747419 ↗ |
| Known as | MSB-0010682 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3833373 ↗ |
| Known as | MSB0010718C | “A PHASE 3, MULTICENTER, MULTINATIONAL, RANDOMIZED, OPEN-LABEL, PARALLEL-ARM STUDY OF AVELUMAB (MSB0010718C) PLUS BEST SUPPORTIVE CARE VERSUS BEST SUPPORTIVE CARE ALONE AS A...” NCT02603432 ↗17“This is a single arm, open label, phase II study to evaluate the activity of avelumab (MSB0010718C) in patients with metastatic or locally advanced urothelial cancer considered...” NCT03891238 ↗ “A RANDOMIZED, OPEN-LABEL, MULTICENTER, PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF AVELUMAB (MSB0010718C) IN COMBINATION WITH AND/OR FOLLOWING CHEMOTHERAPY IN PATIENTS...” NCT02718417 ↗ “A PHASE 3, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY OF AVELUMAB (MSB0010718C) ALONE OR IN COMBINATION WITH PEGYLATED LIPOSOMAL DOXORUBICIN VERSUS PEGYLATED LIPOSOMAL...” NCT02580058 ↗ “A Phase 2, Multi-centre, Open-label Study of Avelumab (MSB0010718C) in Locally Advanced or Metastatic Penile Cancer Patients Unfit for Platinum-based Chemotherapy or Progressed...” NCT03391479 ↗ “A Phase III Open-Label, Multicenter Trial of Avelumab (MSB0010718C) Versus Docetaxel in Subjects With Non-Small Cell Lung Cancer That Has Progressed After a Platinum-Containing Doublet” NCT02395172 ↗ “Avelumab (formerly MSB0010718C) is a human immunoglobulin G1 (IgG1) anti-PD-L1 monoclonal antibody131 that utilizes both adaptive and innate immune mechanisms.” NCT03964532 ↗ “A PHASE 1 PHARMACOKINETIC-PHARMACODYNAMIC STUDY OF AVELUMAB (MSB0010718C) IN PATIENTS WITH PREVIOUSLY TREATED ADVANCED STAGE CLASSICAL HODGKIN'S LYMPHOMA” NCT02603419 ↗ “An Open-Label, Multicenter Follow-up Study to Collect Long-term Data on Participants From Multiple Avelumab (MSB0010718C) Clinical Studies” NCT03815643 ↗ “OF AVELUMAB (MSB0010718C) IN COMBINATION WITH CHEMOTHERAPY WITH OR WITHOUT OTHER ANTI-CANCER IMMUNOTHERAPIES” NCT03317496 ↗ “To test the maximum tolerated dose of avelumab (MSB0010718C) in combination with axitinib (AG-013736)” NCT02493751 ↗ “Maintenance Therapy With Avelumab (MSB0010718C) Versus Continuation of First-line Chemotherapy” NCT02625610 ↗ “Avelumab\* (MSB0010718C; anti-PD-L1 is a fully human anti-PD- L1 IgG1 antibody)” NCT03312114 ↗ “* Study drug: Avelumab (PD-L1 inhibitor; MSB0010718C)” NCT03439501 ↗ “Avelumab (MSB0010718C)” NCT03289533 ↗ “Avelumab (MSB0010718C)” NCT03472560 ↗ “Avelumab (MSB0010718C)” NCT02684006 ↗ |
| Action | Inhibit | “a programmed death-ligand 1 (PD-L1) inhibitor” PMID 32849281 ↗ Aug 2020 |
| Modality | Monoclonal antibody | “Avelumab, an anti-programmed death-ligand 1 monoclonal antibody” PMID 31553054 ↗ Nov 2019 |
| Route | Intravenous | “received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks” NCT01772004 ↗ |
| Target | CD274 | “avelumab (anti-programmed death ligand 1 antibody)” PMID 37236636 ↗ May 2023 |