TIVDAK
BLA 761208 · Biologics License Application (BLA) Prescription
TISOTUMAB VEDOTIN-TFTV
- Sponsor (Drugs@FDA)
- SEAGEN Company: Seagen Inc.
- First approved
- Latest action
Drugs on HealthTrade
Drugs whose FDA actions or confirmed applications cite this number. A drug listed from this record shows “Not yet reviewed” on its page until an editor checks it.
Products
| Product | Name and ingredient | Form and strength | Marketing status | TE code | Reference | Orange Book |
|---|---|---|---|---|---|---|
| 001 | TIVDAK TISOTUMAB VEDOTIN-TFTV | INJECTABLE;INJECTION 40MG | Prescription | – | No | Not listed |
Submissions
| Submission | Status | Status date | Review | Class | Documents |
|---|---|---|---|---|---|
| Supplement 10 | Approved | standard | Labeling | Letter for Supplement 10 (opens in a new tab)Label for Supplement 10 (opens in a new tab) | |
| Supplement 7 | Approved | priority | Efficacy | Letter for Supplement 7 (opens in a new tab)Label for Supplement 7 (opens in a new tab) | |
| Supplement 5 | Approved | standard | Labeling | Letter for Supplement 5 (opens in a new tab)Label for Supplement 5 (opens in a new tab) | |
| Original 1 | Approved | priority | Type 1 - New Molecular Entity | Letter for Original 1 (opens in a new tab)Label for Original 1 (opens in a new tab) |
Orange Book patents
No Orange Book patents are listed for this application.
Orange Book exclusivities
No Orange Book exclusivities are listed for this application.
Purple Book licensure
| Product | Licence | Strength and presentation | Licensed on | First licensure | Reference product | Exclusivity |
|---|---|---|---|---|---|---|
| Tivdak 001tisotumab vedotin-tftv · Seagen Inc. | 351(a) Licensed · Rx | 40MG For Injection · Intravenous · Single-Dose Vial | – | – | – |
Prescription labels
The latest version of each DailyMed label, newest first. Indications and boxed warnings are cut to 1,000 characters; DailyMed has the full label.
TIVDAK Boxed warning
TISOTUMAB VEDOTIN · SEAGEN INC. · INTRAVENOUS · Version 10 · effective
Boxed warning
WARNING: OCULAR TOXICITY • TIVDAK can cause severe ocular toxicities resulting in changes in vision, including severe vision loss, and corneal ulceration. [see Warnings and Precautions (5.1) ]. • Conduct an ophthalmic exam, including an assessment of ocular symptoms, visual acuity, and slit lamp exam of the anterior segment of the eye prior to initiation of TIVDAK, prior to every cycle for the first nine cycles, and as clinically indicated. [see Dosage and Administration (2.2) and Warnings and Precautions (5.1) ] . • Adhere to the required premedication and eye care before, during, and after infusion. [see Dosage and Administration (2.2) ]. • Withhold TIVDAK until improvement and resume, reduce the dose, or permanently discontinue, based on severity [see Dosage and Administration (2.3) , Warnings and Precautions (5.1) ]. WARNING: OCULAR TOXICITY See full prescribing information for complete boxed warning. • TIVDAK can cause severe ocular toxicities resulting in changes in vision, incl…
Indications and usage
1 INDICATIONS AND USAGE TIVDAK ® is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. TIVDAK is a tissue factor-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. ( 1 )
NDC products
1 product in the NDC directory with this application number.
| Product NDC | Name | Labeler | Form and route | Category | Marketing dates |
|---|---|---|---|---|---|
| 51144-003 in openFDA (opens in a new tab) | TIVDAK tisotumab vedotin | SEAGEN INC. | INJECTION, POWDER, FOR SOLUTION INTRAVENOUS | BLA | From |
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FDA drug shortages load here.
Sources
- Drugs@FDA (opens in a new tab)Licence: public-domain. Drugs@FDA download 2026-10-25.
- Purple Book (opens in a new tab)Licence: public-domain. Purple Book purplebook-2026-09.csv.
- openFDA drug labels (DailyMed SPL) (opens in a new tab)Licence: cc0. openFDA drug label download 2026-10-25.
- openFDA NDC directory (opens in a new tab)Licence: cc0. openFDA NDC download 2026-10-25.
Data provided by the U.S. Food and Drug Administration. Showing it here is not an FDA endorsement. openFDA asks: “Do not rely on openFDA to make decisions regarding medical care.”
Patent and exclusivity dates are as FDA lists them and can change. Nothing on this page is medical or investment advice.