Drugs / Tisotumab Vedotin
Tisotumab Vedotin
also known as
HuMax-TF-ADC · GCT1015-04 · IGG1-1015-011-1006 · TF-011-MMAE · Tisotumab vedotin tftv · Tisotumab vedotina · Tisotumab vedotine · Tivdak
Other / unclassified targets F3
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed cervical carcinoma 2 milestones | |||||
| Filed | China (NMPA) | TIVDAK | cervical carcinoma | 2025-03-12 | “In March 2025, China’s National Medical Products Administration (NMPA) accepted the Biologics License Application (BLA) for TIVDAK” zailaboratory.com ↗ |
| Filed | US (FDA) | — | cervical carcinoma | 2021-02-10 | “This BLA requests FDA approval of tisotumab vedotin for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.” genmab.com ↗ “today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval for tisotumab vedotin.” genmab.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Tivdak | — | 2025-03-28 | europa.eu ↗ |
Trials 12
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05866354 | Jun → Nov 2023 | cancer | Zai Lab (Shanghai) Co., Ltd. | Completed | No outcome recorded |
| Phase 1/24 trials | ||||||
| Phase 1/2 | NCT03913741 | Feb 2019 → Aug 2020 | cancer | Genmab | Completed | No outcome recorded |
| Phase 1/2 | NCT03786081 | Feb 2019 → Mar 2026 | cervical cancer | Pfizer | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT02552121 | Nov 2015 → Dec 2017 | castration-resistant prostate carcinoma, cervical cancer, endometrial cancer, esophageal cancer +3 | Seagen Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT02001623 | Nov 2013 → May 2019 | castration-resistant prostate carcinoma, cervical cancer, endometrial cancer, esophageal cancer +4 | Seagen Inc. | Completed | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT07672782 | Nov 2026 → Mar 2029 expected | vulvar squamous cell carcinoma | GOG Foundation | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT03657043 | Mar 2019 → Feb 2022 | fallopian tube cancer, ovarian cancer, peritoneum cancer | Seagen Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03485209 | Jun 2018 → Mar 2026 overdue | colorectal cancer, exocrine pancreatic carcinoma, head and neck squamous cell carcinoma, non-small cell lung carcinoma | Pfizer | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03438396 | Jun 2018 → Feb 2020 | cervical cancer | Seagen Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03245736 | Aug 2017 → Jan 2019 | cervical cancer, endometrial cancer, esophageal cancer, head and neck squamous cell carcinoma +4 | Seagen Inc. | Completed | No outcome recorded |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT04697628 | Feb 2021 → Jul 2023 | cervical cancer | Pfizer | Completed | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT06952660 | May 2025 → Dec 2028 expected | cervical cancer | Pfizer | Recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT06459180 Comparator | Jul 2024 → Jun 2028 expected | cervical cancer | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2026-06-08 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab Receives China NMPA Approval of TIVDAK® (tisotumab vedotin for injection) for the Treatment of Adult Patients with Recurrent or Metastatic Cervical Cancer zailaboratory.com ↗
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that China’s National Medical Products Administration (NMPA) has approved the Biologics License Application (BLA) for TIVDAK® (tisotumab vedotin for injection) for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. |
| 2025-09-01 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab Announces Approval of TIVDAK® for Patients with Recurrent or Metastatic Cervical Cancer in Hong Kong zailaboratory.com ↗
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced the Hong Kong Department of Health has approved TIVDAK (tisotumab vedotin-tftv) in Hong Kong for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. |
| 2025-03-12 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab Announces Acceptance of Biologics License Application for TIVDAK for the Treatment of Patients with Recurrent or Metastatic Cervical Cancer zailaboratory.com ↗
Zai Lab Announces Acceptance of Biologics License Application for TIVDAK for the Treatment of Patients with Recurrent or Metastatic Cervical Cancer |
| 2025-01-15 | Zai Lab (Shanghai) Co., Ltd. | Results Zai Lab Announces Positive Topline Results for TIVDAK in the China Subpopulation of the Global Phase 3 innovaTV 301 Trial in Patients with Recurrent or Metastatic Cervical Cancer zailaboratory.com ↗
Median OS for patients treated with TIVDAK was not reached versus chemotherapy 10.7 months [95% CI: 6.0-not reached] with a median follow-up of 11.5 months. |
| 2024-04-30 | Genmab | Regulatory TIVDAK® (tisotumab vedotin-tftv) Receives U.S. FDA Approval to Treat Recurrent or Metastatic Cervical Cancer genmab.com ↗
This FDA action converts the September 2021 accelerated approval of TIVDAK to a full approval. |
| 2024-04-29 | Pfizer | Regulatory FDA Grants Full Approval for TIVDAK® to Treat Recurrent or Metastatic Cervical Cancer pfizer.com ↗
Pfizer Inc. (NYSE: PFE) and Genmab A/S (Nasdaq: GMAB) today announced the U.S. Food and Drug Administration (FDA) approves the supplemental Biologics License Application (sBLA) granting full approval for TIVDAK ® (tisotumab vedotin-tftv) for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. |
| 2024-01-09 | Pfizer | Regulatory TIVDAK® Supplemental Biologics License Application Accepted for Priority Review by FDA for Patients with Recurrent or Metastatic Cervical Cancer pfizer.com ↗
The application has been granted Priority Review with a Prescription Drug User Fee Act (PDUFA) goal date of May 9, 2024. |
| 2023-09-04 | Genmab | Results Genmab and Seagen Announce That TIVDAK® (tisotumab vedotin-tftv) Met its Primary Endpoint of Improved Overall Survival in Patients with Recurrent or Metastatic Cervical Cancer Compared to Chemotherapy genmab.com ↗
An Independent Data Monitoring Committee determined that OS crossed the pre-specified efficacy boundary at interim analysis. |
| 2021-09-20 | Genmab | Regulatory Genmab and Seagen Announce FDA Accelerated Approval for TIVDAK™ (tisotumab vedotin-tftv) in Previously Treated Recurrent or Metastatic Cervical Cancer genmab.com ↗
Genmab A/S (Nasdaq: GMAB) and Seagen Inc. (Nasdaq: SGEN) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to TIVDAKTM (tisotumab vedotin-tftv), the first and only approved antibody-drug conjugate (ADC) for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. |
| 2021-04-09 | Genmab | Regulatory Genmab and Seagen Announce U.S. FDA Filing Acceptance for Priority Review of Tisotumab Vedotin Biologics License Application for Patients with Recurrent or Metastatic Cervical Cancer genmab.com ↗
Genmab A/S (Nasdaq: GMAB) and Seagen Inc. (Nasdaq: SGEN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) seeking accelerated approval for tisotumab vedotin. |
| 2021-02-10 | Genmab | Regulatory Genmab and Seagen Submit Tisotumab Vedotin Biologics License Application to the U.S. FDA for Patients with Recurrent or Metastatic Cervical Cancer genmab.com ↗
Genmab A/S (Nasdaq: GMAB) and Seagen Inc. (Nasdaq: SGEN) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval for tisotumab vedotin. |
All press releases naming this drug 12 releases
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 16 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | tisotumab vedotin | “Participants will receive tisotumab vedotin by IV infusion.” NCT06952660 ↗ |
| Known as | GCT1015-04 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297841 ↗ |
| Known as | HuMax-TF-ADC | “The purpose of the trial is to establish the tolerability of tisotumab vedotin (HuMax-TF-ADC) dosed three times every four weeks (3q4wk) in a mixed population of patients with...” NCT02552121 ↗4“A Phase 1b/2 Open-Label Trial of Tisotumab Vedotin (HuMax®-TF-ADC) Monotherapy and in Combination With Other Agents in Subjects With Recurrent or Stage IVB Cervical Cancer” NCT03786081 ↗ “A Single Arm, Multicenter, International Trial of Tisotumab Vedotin (HuMax®-TF-ADC) in Previously Treated, Recurrent or Metastatic Cervical Cancer” NCT03438396 ↗ “All patients in the trial will be administered tisotumab vedotin (HuMax-TF-ADC).” NCT03245736 ↗ “Tisotumab Vedotin (HuMax-TF-ADC)” NCT02001623 ↗ |
| Known as | IGG1-1015-011-1006 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297841 ↗ |
| Known as | TF-011-MMAE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297841 ↗ |
| Known as | Tisotumab vedotin tftv | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297841 ↗ |
| Known as | Tisotumab vedotina | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297841 ↗ |
| Known as | Tisotumab vedotine | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297841 ↗ |
| Known as | Tivdak | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297841 ↗ |
| Modality | Other / unclassified | “Tisotumab vedotin (TV), a tissue factor-directed antibody-drug conjugate (ADC)” PMID 41044356 ↗ Oct 2025 |
| Route | Intravenous | “treated with tisotumab vedotin between 0·3 and 2·2 mg/kg intravenously once every 3 weeks” PMID 30745090 ↗ Feb 2019 |
| Target | F3 | “Coagulation factor III binding agent” CHEMBL4297841 ↗ |