Treats recurrent or metastatic cervical cancer with disease progression on or after…. BLA 761208, held by Seagen. Tisotumab Vedotin-Tftv.
As of Nov 13, 2026, BLA 761208 (Tivdak), held by Seagen, was first approved by FDA on Sep 20, 2021, with 3 approved supplements and 0 published complete response letters.
TIVDAK is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 29, 2024 | Supplement 7Efficacy (new indication or use) · Priority review | Approved | |
| Sep 20, 2021 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tivdak40MG · injectable;injection | Tisotumab Vedotin-Tftv | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 12, 2025 | Supplement 10Labeling · Standard review | Approved | |
| Apr 29, 2024 | Supplement 7Efficacy (new indication or use) · Priority review | Approved | |
| Jul 26, 2023 | Supplement 5Labeling · Standard review | Approved | |
| Sep 20, 2021 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
