Tivdak

Cervical cancer — recurrent or metastatic, with disease progression on or after chemotherapy

2.0 mg/kg (max 200 mg) IV every 3 weeks until disease progression or unacceptable toxicity
Infuse over 30 minutes (do not exceed 200 mg per dose)
Do NOT use in-line filter

For injection: 40 mg lyophilized powder in single-dose vial

None listed.

• Ocular Toxicity: 53% (Grade ≥3: 3%). Including conjunctivitis (27%), dry eye (16%), keratitis (7%), changes in visual acuity (12%). Ophthalmologic exam at baseline, before each dose, and as indicated. Use vasoconstrictor eye drops, lubricating eye drops, cooling eye packs during infusion. Avoid contact lenses.
• Peripheral Neuropathy: 42% (3% Grade ≥3). Primarily sensory. Monitor and dose-modify.
• Hemorrhage: 62% (5% Grade ≥3). Including epistaxis (42%), vaginal hemorrhage, GI hemorrhage. Permanently discontinue for Grade ≥3 hemorrhage.
• Pneumonitis: 2% (1% Grade ≥3). Withhold for suspected pneumonitis.
• Embryo-Fetal Toxicity

Epistaxis (42%), nausea (30%), fatigue (28%), conjunctivitis (27%), hemorrhage (62%), alopecia (26%), peripheral neuropathy (42%), diarrhea (20%), decreased appetite (16%), vomiting (14%), dry eye (16%)

Ocular toxicity in 50% (conjunctivitis 30%, dry eyes 23%, keratitis 10%). Requires lubricating eye drops and ophthalmic exams. Permanently D/C for corneal ulceration.

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

Ocular toxicity in 50% (conjunctivitis 30%, dry eyes 23%, keratitis 10%). Requires lubricating eye drops and ophthalmic exams. Permanently D/C for corneal ulceration.

Consult the complete prescribing information for drug interactions, including effects on CYP enzymes, transporters, and concomitant medications that may require dose adjustments or monitoring.

Consult the full prescribing information for pregnancy-related considerations.

Refer to prescribing information for lactation guidance.

Pediatric safety and efficacy information is detailed in the full label.

Dose modifications for organ impairment are specified in the complete prescribing information.

Tisotumab vedotin is an antibody-drug conjugate comprising a human anti-tissue factor (TF) IgG1 monoclonal antibody conjugated to MMAE via a protease-cleavable MC-vc-PAB linker. Tissue factor is a transmembrane protein overexpressed on many solid tumors, including cervical cancer. Upon TF binding and internalization, MMAE is released intracellularly, disrupting the microtubule network and inducing cell cycle arrest and apoptosis. Additionally, the bystander effect of released MMAE can kill nearby TF-negative tumor cells.

Tmax: end of infusion. ADC half-life: approximately 3.1 days. Payload (MMAE) half-life: 2-4 days. Clearance: 1.63 L/day. Vd: 9.3 L. MMAE metabolized by CYP3A4. Steady-state by Cycle 3.

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

• innovaTV 204 — Tisotumab vedotin in recurrent/metastatic cervical cancer after ≥1 prior therapy. Phase II, n=101.
  🔬 NCT03438396 ↗ 📄 Primary Publication ↗

Tivdak has FDA-approved indications across the following cancer types covered on PipelineEvidence: