SpringWorks Therapeutics Receives US FDA Approval for Gomekli to Treat Neurofibromatosis Type 1 Associated Symptomatic Plexiform Neurofibromas (NF1-PN)
Shots:
- The US FDA has approved Gomekli for pts (≥2 years) with unresectable NF1-PN based on P-IIb (ReNeu) trial & has also granted RPD PRV to SpringWorks; availability in US market is expected within 2wks; MAA is under EMA review with decision expected in 2025
- The P-IIb (ReNeu) study assessed Gomekli (2mg/m^2, BID) in 2 Arms (N=114: 56 pediatric & 58 adults) & met its 1EP of ORR (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: Globenewswire | Image: SpringWorks Therapeutics
Related News:- SpringWorks Therapeutics Receives the US FDA Approval for Ogsiveo (nirogacestat) for the Treatment of Desmoid Tumors
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