^
Association details:
| Biomarker: | No biomarker |
|---|---|
| Cancer: | Cervical Cancer |
| Drug: | Tivdak (tisotumab vedotin-tftv) (Microtubule inhibitor, Human TF-targeted antibody-drug conjugate) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
TIVDAK® (tisotumab vedotin-tftv) Receives U.S. FDA Approval to Treat Recurrent or Metastatic Cervical Cancer
Published date:
04/29/2024
Excerpt:
...U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for TIVDAK® (tisotumab vedotin-tftv) for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.
Trial ID:
Source:
Published date:
10/26/2021
Excerpt:
Cervical Cancer: Second-line or Subsequent Therapy...Other Recommended Regimens...Tisotumab vedotin-tftv
Source:
Title:
288MO - InnovaTV 301/ENGOT-cx12/GOG-3057: A global, randomized, open-label, phase III study of tisotumab vedotin vs investigator’s choice of chemotherapy in 2L or 3L recurrent or metastatic cervical cancer
Published date:
11/27/2023
Excerpt:
The TV arm had a 30% reduction in risk of death vs chemotherapy (HR 0.70; 95% CI 0.54-0.89; P=0.0038), with significantly longer median OS (11.5 mo [95% CI 9.8-14.9] vs 9.5 mo [95% CI 7.9-10.7]). PFS was superior in the TV vs chemotherapy arm (HR: 0.67 [95% CI, 0.54-0.82]; P<0.0001). Confirmed ORR was 17.8% and 5.2% in the TV and chemotherapy arms, respectively (odds ratio: 4.0; 95% CI, 2.1-7.6; P<0.0001)....In the phase 3 innovaTV 301 study, TV showed a statistically significant and clinically meaningful improvement in OS, PFS, and ORR vs chemotherapy, with a manageable and tolerable safety profile in pts with 2L/3L r/mCC.
Trial ID:
Source:
Title:
Seagen and Genmab Announce TIVDAK® (tisotumab vedotin-tftv) Improved Overall Survival in Patients With Recurrent or Metastatic Cervical Cancer Compared With Chemotherapy Alone
Published date:
09/04/2023
Excerpt:
Seagen Inc...and Genmab A/S...announced today that the Phase 3 innovaTV 301 global trial in recurrent or metastatic cervical cancer patients with disease progression on or after front-line therapy who received TIVDAK (tisotumab vedotin-tftv), compared with chemotherapy alone, met its primary endpoint of overall survival (OS).
Trial ID:
Source:
Title:
Seagen and Genmab Announce U.S. FDA Filing Acceptance for Priority Review of Tisotumab Vedotin Biologics License Application for Patients with Recurrent or Metastatic Cervical Cancer
Published date:
04/09/2021
Excerpt:
Seagen Inc. (Nasdaq: SGEN) and Genmab A/S (Nasdaq: GMAB) 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....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.
