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Grape membrane melanoma is the most common intraocular tumor, and in China, the incidence rate is second only to retinal scleoma, ranking second in intraocular tumors.
Immunocore, a late-stage biotechnology company dedicated to developing new T-cell-specific (TCR) dual-specific immunotherapy, announced today that the U.S. Food and Drug Administration (FDA) has awarded tebentafusp (IMCgp100) a "breakthrough therapy title" (BTD) for the treatment of adult patients with non-removable or metastasis staphylocolum melanoma (mUM).
In a randomized Phase III clinical trial (IMCgp100-202 study) in patients with previously untreated metastasis membrane melanoma, an interim analysis showed that tebentafusp significantly extended total patient survival (OS) and was superior to other immunotherapy therapies, so the trial reached its primary endpoint.
, Tebentafusp was awarded the FDA's "fast track qualification" and "orphan drug title" as well as the "promising innovative drug title" under the UK's early drug program.
Immunocore will work with the FDA to facilitate the launch of tebentafusp.
if approved, Immunocore believes tebentafusp will be a new treatment for metastasis vine melanoma over 40 years.
Bahija Jallal, Chief Executive Officer of Immunocore, said,
We are pleased that the FDA has awarded tebentafusp a breakthrough therapy based on the survival benefits of our Phase III clinical trial announced in November 2020.
patients urgently need approved treatments to treat this rare and aggressive melanoma."