04:56 AM EST, 02/12/2025 (MT Newswires) -- SpringWorks Therapeutics ( SWTX ) said late Tuesday the US Food and Drug Administration has approved Gomekli, or mirdametinib, for the treatment of certain patients with neurofibromatosis type 1, a genetic disorder with symptoms including abnormal pigmentation and tumor growth.

The approval is based on findings from a phase 2b trial in which Gomekli showed a 41% objective response rate in adults and 52% in children, the company said.

SpringWorks received a rare pediatric disease priority review voucher and intends to make Gomekli available in the US within two weeks, it said.

The company also said it is seeking mirdametinib approval from the European Medicines Agency, with a decision expected this year.