Tisotumab vedotin-tftv

(Tivdak®)

Tivdak®

Drug updated on 10/25/2024

Dosage FormInjection (intravenous; 40 mg)
Drug ClassTissue factor-directed antibodies and microtubule inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

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Summary
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  • This summary is based on the review of one randomized controlled trial(s). [1]
  • Tisotumab vedotin showed a median overall survival (OS) of 11.5 months (95% CI (Confidence interval), 9.8 to 14.9) compared to 9.5 months (95% CI, 7.9 to 10.7) with chemotherapy, with a 30% lower risk of death (HR (Hazard Ratio) 0.70; 95% CI, 0.54 to 0.89; P = 0.004).
  • Progression-free survival (PFS) was significantly longer with tisotumab vedotin at 4.2 months (95% CI, 4.0 to 4.4) compared to 2.9 months (95% CI, 2.6 to 3.1) for chemotherapy (HR 0.67; 95% CI, 0.54 to 0.82; P < 0.001).
  • The objective response rate (ORR) for tisotumab vedotin was 17.8%, significantly higher than the 5.2% seen with chemotherapy (OR 4.0; 95% CI, 2.1 to 7.6; P < 0.001).
  • Tisotumab vedotin was associated with an overall adverse event (AE) incidence of 98.4%, with 52.0% of patients experiencing grade 3 or greater AEs, compared to chemotherapy, which had a 99.2% incidence of AEs and 62.3% for grade 3 or greater AEs.
  • Treatment discontinuation due to toxic effects occurred in 14.8% of patients treated with tisotumab vedotin.
  • The study population consisted of patients with recurrent or metastatic cervical cancer who were receiving second- or third-line therapy. No specific subgroup analyses were reported, and the treatment groups for tisotumab vedotin and chemotherapy were similar in terms of demographic and disease characteristics.

Product Monograph / Prescribing Information

Document TitleYearSource
Tivdak (tisotumab vedotin-tftv) Prescribing Information.2024Seagen Inc., Bothell, WA

Randomized Controlled Trials

Document TitleSex DistributionYearSource
Tisotumab Vedotin as Second- or Third-Line Therapy for Recurrent Cervical Cancer
502Subjects
F: 100%
M: 0%
2024The New England Journal of Medicine

Sex Distribution:

F:100%
M:0%
502Subjects

Year:

2024

Source:The New England Journal of Medicine