From GlobeNewswire: 2025-02-11 20:20:22

SpringWorks Therapeutics announced FDA approval for GOMEKLI, the first medicine for adults and children with NF1-PN. The approval was based on positive data from the Phase 2b ReNeu trial showing robust reductions in tumor volume and a manageable safety profile. The rare pediatric disease priority review voucher was granted. NF1 affects about 100,000 in the U.S., with approximately 40,000 living with NF1-PN. Plexiform neurofibromas can be challenging to remove due to their growth pattern. GOMEKLI demonstrated deep tumor reductions and durable responses with manageable safety. The drug is available in the U.S. and under EMA review.



Read more at GlobeNewswire: SpringWorks Therapeutics Announces FDA Approval of