Is Tisotumab vedotin-tftv on the market?

On September 20, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Tisotumab vedotin-tftv for the treatment of adults with recurrent or metastatic cervical cancer who have experienced disease progression during or after chemotherapy. This is the first and only antibody-drug conjugate approved for this therapeutic indication. Approval was based on tumor response and durability of response, as shown in InnovaTV 204: In this trial, the objective response rate was 24% and the median duration of response was 8.3 months. Vitin-Tisotuzumab is marketed as an intravenous injection under the trade name Tivdak.

Vitin-Tisotuzumab is also currently being investigated for the treatment of other solid tumors, including ovarian, lung, colorectal, pancreatic, and head and neck cancers. It is also being studied in combination with other chemotherapy drugs to treat recurrent or metastatic cervical cancer. In the United States, Vitin-Tisotuzumab carries a black box warning for ocular toxicity, which occurs in up to 60% of treated patients. In clinical trials, the most common ocular toxicities were dry eye, conjunctivitis, corneal damage, and blepharitis, and other common side effects included bleeding (in approximately 60% of patients, most commonly nosebleeds) and peripheral neuropathy (42% of patients). Like all MMAE-containing drugs, Vitin-Tisotuzumab can cause inflammation of the lungs.

Vitin-TisotumabThe original drug has not yet been marketed in China, so it cannot be included in medical insurance. The original drugs marketed overseas are very expensive. The price of each box of 40 mg/vial may be around RMB 90,000 (the price may fluctuate due to the exchange rate). Currently, there is no generic version of Vitin-Tisotuzumab on the market. For more drug information and specific prices, please consult the medical consultant of the drug.