3 days ago · The FDA approval of GOMEKLI is based on results from the Phase 2b ReNeu trial, which enrolled 114 patients with NF1-PN ≥2 years of age (58 adults and 56 pediatric patients). …

2 days ago · The FDA approval of GOMEKLI is based on results from the Phase 2b ReNeu trial, which enrolled 114 patients with NF1-PN ≥2 years of age (58 adults and 56 pediatric patients). …

3 days ago · GOMEKLI is available in 2 dosage forms: capsules or tablets for oral suspension. • GOMEKLI capsules: must be swallowed whole, do not open, break or chew capsules. • …

2 days ago · The FDA approval of GOMEKLI is based on results from the Phase 2b ReNeu trial, which enrolled 114 patients with NF1-PN ≥2 years of age (58 adults and 56 pediatric patients). …

2 days ago · Both Gomekli and Koselugo are kinase inhibitors that target mitogen-activated protein kinase kinases 1 and 2. These enzymes are responsible for cell growth and are …

3 days ago · Gomekli capsules and tablets for oral suspension are administered orally twice daily, with or without food, for the first 21 days of each 28-day cycle until disease progression or …

1 day ago · Gomekli is SpringWorks’ second FDA approval in the past 15 months. The company, a Pfizer spinout founded in 2017, specializes in developing treatments for rare diseases. In …

2 days ago · Potential Positives. GOMEKLI is the first and only approved treatment for both adults and children with neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN), …

2 days ago · Gomekli is supplied as a capsule in 1mg and 2mg dosage strengths, as well as a 1mg tablet for oral suspension. The tablets for oral suspension can be swallowed whole or …

2 days ago · Gomekli demonstrated an ORR of 41% in adults and 52% in children, with durable tumor reductions and improvements in pain and quality of life. Additionally, 80% of adults and …