Is Tisotumab vedotin approved by the FDA?

Tisotumab vedotin (Tivdak) received accelerated approval from the US Food and Drug Administration (FDA) on September 20, 2021. This approval offers a new treatment option for patients with advanced cervical cancer, especially those whose disease has progressed despite prior treatments.Tisotumab vedotin, marketed under the brand name Tivdak, is an intravenous medication classified under miscellaneous antineoplastics. 

Indications and Usage

Tisotumab vedotin is prescribed for adult patients with recurrent or metastatic cervical cancer whose disease has progressed during or after chemotherapy. This medication is used when other treatments have not worked or have stopped working, offering hope to patients with limited options.

Mechanism of Action

Tisotumab vedotin works by delivering a cytotoxic agent directly to the cancer cells. The medication is composed of a monoclonal antibody (tisotumab) linked to a microtubule-disrupting agent (vedotin). The antibody binds to tissue factor (TF) expressed on cancer cells, and the cytotoxic agent is then released inside the cells, leading to cell death.

Administration and Dosage

The recommended dosage of tisotumab vedotin is 2 mg/kg (up to a maximum of 200 mg for patients 100 kg or greater) administered as an intravenous infusion over 30 minutes every three weeks until disease progression or unacceptable toxicity.

Patients need to follow a strict premedication and eye care regimen:

• Eye Examinations: An ophthalmic exam, including visual acuity and slit lamp exam, is required at baseline, before each dose, and as needed.
• Eye Medications: Patients receive three different eye medications: steroid eye drops, vasoconstrictor eye drops, and lubricating eye drops. These are used before, during, and after each infusion.
• Avoiding Contact Lenses: Patients should avoid wearing contact lenses unless advised by their eye care provider.

Side Effects

Tisotumab vedotin can cause various side effects, some of which may be serious. Important side effects include:

• Serious Side Effects:
  • Vision changes, eye redness, dryness, or irritation.
  • New or worsening cough, trouble breathing.
  • Severe stomach cramps, bloating, nausea, vomiting, constipation.
  • Uncontrolled bleeding, nerve problems, low blood cell counts.
• Common Side Effects:
  • Dry eyes.
  • Fever, low red or white blood cells.
  • Nausea, diarrhea.
  • Fatigue.
  • Nosebleeds.
  • Numbness or tingling.
  • Hair loss.
  • Rash.
  • Abnormal kidney function or blood-clotting tests.

Patients should report any severe side effects to their healthcare provider immediately, as some side effects may require delaying or permanently discontinuing treatment.

Precautions and Interactions

Before starting tisotumab vedotin, patients should inform their healthcare provider about any pre-existing conditions, such as:

• Vision or eye problems.
• Bleeding disorders.
• Liver disease.
• Neuropathy (numbness or tingling in hands and feet).

Pregnancy and Breastfeeding

Tisotumab vedotin can harm an unborn baby. Women who can become pregnant should use effective birth control during treatment and for at least two months after the last dose. Men with partners who can become pregnant should use birth control during treatment and for at least four months after the last dose. Breastfeeding is not recommended during treatment and for at least three weeks after the last dose.

Conclusion

Tisotumab vedotin (Tivdak) offers a promising treatment for patients with recurrent or metastatic cervical cancer, receiving FDA approval on September 20, 2021. This approval provides a critical option for those with limited alternatives, underscoring the importance of ongoing cancer research and the development of targeted therapies. Patients should closely follow their healthcare provider's instructions and report any adverse effects promptly to ensure the best possible outcomes.

How to obtain the latest development progress of all drugs?

In the Synapse database, you can stay updated on the latest research and development advances of all drugs. This service is accessible anytime and anywhere, with updates available daily or weekly. Use the "Set Alert" function to stay informed. Click on the image below to embark on a brand new journey of drug discovery!