Shots:
- The US FDA has accepted the NDA for Immunome’s varegacestat for the treatment of adults with desmoid tumors, with a PDUFA target action date of Apr 28, 2027
- NDA is supported by the global P-III (RINGSIDE) trial assessing varegacestat (1.2mg, QD) vs PBO until disease progression or death in 156 pts with progressing desmoid tumors; eligible pts could then enter the OLE phase, which is ongoing
- Trial met its 1EP, improving PFS by 84%, plus the ORR was 56% vs 9% per BICR; varegacestat also showed median best change in tumor volume of -83% vs +11%, along with pain improvement at Wk. 12 & clinically significant difference observed as early as the first evaluation at Wk. 4
Ref: Businesswire | Image: Immunome |Press Release
Related News: Immunome Reports the US FDA’s NDA Submission for Varegacestat to Treat Desmoid Tumors in Adults
PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with us at connect@pharmashots.com
