08:51 AM EDT, 05/23/2025 (MT Newswires) -- Springworks Therapeutics ( SWTX ) said Friday that mirdametinib received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use, which recommends a conditional marketing authorization to treat plexiform neurofibromas in patients with neurofibromatosis type 1.

The opinion of the Committee will be reviewed by the European Commission, which is expected to make a final decision about the approval in Q3, the company said.

If approved, mirdametinib is expected to be the first and only treatment in the EU with marketing authorization for both adults and children with neurofibromatosis type 1 associated plexiform neurofibromas or NF1-PN, a genetic disorder, the company said.

The Committee's opinion was based on the marketing authorization application for mirdametinib that centered on the primary results from the phase 2b trial, which met the primary endpoint of confirmed objective response rate, the company said.