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

February 22, 2021 Auto Bot Breakthrough Therapy Designation, FDA, receives, regulatory, Unresectable 0

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

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: Linkedin

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