Immunocore’s lead asset tebentafusp (IMCgp100) has gained Fast Track Designation for the treatment of metastatic uveal melanoma (mUM).
The T Cell Receptor (TCR) biotechnology company announced the US Food and Drug Administration’s (FDA) decision for patients who are HLA-A*0201-positive with previously untreated mUM.
The designation was based on the IMCgp100-202 trial, a randomised study of the drug compared with the Investigator's Choice (dacarbazine, ipilimumab or pembrolizumab).
Tebentafusp has already been granted orphan drug designation for melanoma by the FDA and Promising Innovative Medicine designation under UK Early Access to Medicines Scheme.
“For patients with metastatic uveal melanoma, the prognosis is poor and has not meaningfully changed in decades. Our goal is to test whether tebentafusp can prolong survival for these patients,” commented David Berman, head of R&D of Immunocore. “We are delighted that tebentafusp has been granted Fast Track Designation.”
The FDA's Fast Track programme is designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.