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SpringWorks Therapeutics Announces FDA Approval of GOMEKLI™ (mirdametinib) for the Treatment of Adult and Pediatric Patients with NF1-PN
SWTXSpringWorks Therapeutics(SWTX) GlobeNewswire News Room·2025-02-11 22:27

– GOMEKLI is the first and only medicine approved for both adults and children with NF1-PN – – Approval based on positive data from Phase 2b ReNeu trial, which showed GOMEKLI treatment resulted in robust ORR, deep and durable reductions in tumor volume, and a manageable safety profile – – SpringWorks granted rare pediatric disease priority review voucher by the FDA – Photos accompanying this announcement are available at: https://www.globenewswire.com/NewsRoom/AttachmentNg/8eb8effc-49a5-4b24-911f-d3e6dfa9c8 ...