Is Tebentafusp-tebn on the market?

On January 26, 2022, the U.S. Food and Drug Administration (FDA) approved Tebentafusp-tebn for the first time for the treatment of adults with HLA-A*02:01-positive unresectable or metastatic uveal melanoma. This approval marks the first FDA-approved bispecific T-cell engager for the treatment of a solid tumor and the first and only FDA-approved therapy for the treatment of unresectable or metastatic uveal melanoma. Tebenfos was subsequently approved in the EU for the same indication in April 2022, with major studies showing meaningful improvements in overall survival. Side effects were considered manageable but could be serious, especially during the first 3 doses of treatment, and patients should be hospitalized for the first 3 doses.

Uveal melanoma is a rare ocular tumor with generally poor prognosis and limited treatment options. Even after surgical resection or removal of ocular tumors, nearly 50% of patients with uveal melanoma will develop metastatic disease. Tebenforsi is a gp100 peptide-HLA-directed CD3 T cell conjugate, a bispecific fusion protein, and the first of its kind for immune-mobilizing monoclonal T cell receptors against cancer (ImmTACs), a recently developed cancer immunotherapy with a novel mechanism of action. ImmTACs bind to target cancer cells expressing specific target antigens and recruit cytotoxic T cells to lyse cells, such as melanocytes.

The original drug of Tibenforsi is not currently on the market in China, nor has it been included in medical insurance. After Tebenforx is approved for marketing, there may be less price and other related information. For more drug information and specific prices, please consult a medical consultant.