FDA grants priority review to tebentafusp for metastatic uveal melanoma

Source: Healio, January 2022

The FDA approved tebentafusp-tebn for the treatment of adults with HLA-A*02:01-positive unresectable or metastatic uveal melanoma.

Tebentafusp-tebn (Kimmtrak, Immunocore) — the only FDA-approved treatment for this indication — is the first T-cell receptor therapeutic to receive regulatory approval.

Tebentafusp-tebn is a bispecific protein composed of a soluble T-cell receptor fused to an anti-CD3 immune-effector function. The agent targets gp100, a lineage antigen expressed in melanocytes and melanoma.

“Uveal melanoma is a devastating disease that has historically resulted in death within a year of metastasis for our patients,” John Kirkwood, MD, director of the Melanoma Center at the UPMC Hillman Cancer Center, said in an Immunocore-issued press release. “The approval of Kimmtrak represents a major paradigm shift in the treatment of metastatic uveal melanoma and, for the first time, offers hope to those with this aggressive form of cancer.”