FDA Approves Tivdak for Treatment of Advanced Cervical Cancer

Yusimry Approved as Humira Biosimilar
September 20, 2021
Opzelura Cream Approved to Treat Atopic Dermatitis
September 21, 2021
Yusimry Approved as Humira Biosimilar
September 20, 2021
Opzelura Cream Approved to Treat Atopic Dermatitis
September 21, 2021

September 20, 2021 – TivdakTM (tisotumab vedotin-tftv) is now U.S. FDA approved to treat recurrent or metastatic cervical cancer in patients whose disease has progressed on or after chemotherapy.

  • Manufactured by Genmab and Seagen, it is the first antibody-drug conjugate to be FDA approved for this indication.
  • Recommended dosing is 2mg/kg of the patient’s body weight, up to a maximum of 200mg, given via 30-minute intravenous infusion every three weeks until disease progression or unacceptable toxicity occur.
  • Tivdak has a wholesale acquisition cost (WAC) of $5,885 per 40mg single-dose vial.