Shots:
- The CHMP has recommended conditional approval of mirdametinib for pts (≥2yrs.) with unresectable neurofibromatosis type 1 associated symptomatic plexiform neurofibromas (NF1-PN) based on P-IIb (ReNeu) trial; EC’s decision expected in Q3’25
- The P-IIb (ReNeu) study assessed mirdametinib (2mg/m^2, BID) in 2 Arms (N=114: 56 pediatric & 58 adults) & met its 1EP of cORR (52% & 41%) with durable tumor volume reduction of -42% (Range: -91 to 48%) & -41% (Range: -90 to 13%)
- 90% children & 88% adults had response of at least 12mos., while 48% & 50% had responses for ≥24 mos. Both groups showed early, sustained pain relief & improved quality of life
Ref: SpringWorks Therapeutics| Image: SpringWorks Therapeutics| Press Release
Related News:- Merck KGaA to Acquire SpringWorks Therapeutics for ~$3.9B
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