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Immunocore's Tebentafusp Receives the US FDA's Breakthrough Therapy Designation for Unresectable or Metastatic Uveal Melanoma

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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

Click here to­ read the full press release 

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