Immunocore's Tebentafusp Receives the US FDA's Breakthrough Therapy Designation for Unresectable or Metastatic Uveal Melanoma
Shots:
- The US FDA has granted BTD to the tebentafusp (IMCgp100) for the treatment of HLA-A*02:01-positive adult patients with unresectable/ mUM
- The pre-planned interim analysis of a P-III study (IMCgp100-202) in prior untreated muM demonstrated superior OS as monothx. Immunocore will be working with the FDA to facilitate the submission of a BLA for the therapy
- Tebentafusp is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function and has received the US FDA’s ODD and FTD and Promising Innovative Medicine designation under the UK Early Access to Medicines Scheme. If approved- tebentafusp would be the first new therapy in this space
Ref: GlobeNewswire | Image: Linkedin
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