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Immunocore Receives EMA’s CHMP Positive Opinion for Kimmtrak (tebentafusp) to Treat Unresectable or Metastatic Uveal Melanoma

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Immunocore Receives EMA’s CHMP Positive Opinion for Kimmtrak (tebentafusp) to Treat Unresectable or Metastatic Uveal Melanoma

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  • The EMA’s CHMP has adopted a positive opinion recommending the approval of Kimmtrak for mUM
  • The recommendation was based on the P-III (IMCgp100-202) trial to evaluate Kimmtrak vs pembrolizumab, ipilimumab, or dacarbazine in a ratio (2:1) in 378 patients with mUM. The results showed an OS benefit with m-OS of 22mos., OS in the ITT population (82% pembrolizumab; 13% ipilimumab; 6% dacarbazine), treatment-related adverse reactions were manageable & consistent with proposed MoA
  • The company has launched a KIMMTRAKConnect program to provide access to patients treated with Kimmtrak. The therapy received BTD, FTD & ODD from the US FDA, accelerated assessment from the EMA & PIM designation under EAMS for mUM

 Ref: Globe Newswire | Image: Linkedin

Click here to­ read the full press release 

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