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 tebentafusp-tebn (Kimmtrak)

A novel drug, the first in its class, was approved on Jan 27, 2022 by the US Food and Drug Administration (FDA) for use in the treatment of certain patients with metastatic uveal melanoma, a rare cancer of the eye that is often fatal once it has spread to other parts of the body.  However, the indication specifies that the drug is for use only in patients who are HLA-A*02:01-positive.

The drug is tebentafusp-tebn (Kimmtrak, from Immunocore Limited), which acts as a bispecific gp100 peptide-HLA-directed CD3 T-cell engager. It is the first of a novel class of T-cell receptor (TCR) bispecific immunotherapies under development at the company.

It is also the first and only therapy for the treatment of unresectable or metastatic uveal melanoma to be approved by the FDA, and it is the first therapy to demonstrate a survival benefit to patients with this disease, the company noted in a press release.

"Uveal melanoma is a devastating disease that has historically resulted in death within a year of metastasis for our patients," said John Kirkwood, MD, director of the Melanoma Center at the UPMC Hillman Cancer Center. This new approval "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."
( ​news

 特本副丝 (Kimmtrak)

美国食品和药物管理局(FDA)已经批准了一种新型药物,这是同类药物中的第一种用于治疗转移性葡萄膜黑色素瘤患者。这是一种罕见的眼部癌症,一旦扩散到身体其他部位,往往是致命的。 FDA规定该药物仅用于HLA-A*02:01阳性的患者。

该药物是特本副丝 (Kimmtrak,来自Immunocore公司),它作为一种双特异性gp100肽-HLA导向的CD3 T细胞接合剂。这是Immunocore公司正在开发的一类新型T细胞受体(TCR)双特异性免疫疗法中的第一个。


"UPMC癌症中心黑色素瘤中心主任John Kirkwood博士说:"葡萄膜黑色素瘤是一种毁灭性的疾病,历来导致我们的病人在转移后一年内死亡。这项新批准代表了治疗转移性葡萄膜黑色素瘤的重大模式转变,并首次为这种侵略性的癌症患者提供了希望"。

( 新闻)

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