Immunocore Receives EMA’s CHMP Positive Opinion for Kimmtrak (tebentafusp) to Treat Unresectable or Metastatic Uveal Melanoma
Shots:
- 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
This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com