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