Story · Medicine & Biotech

FDA expands pediatric indication for entrectinib and approves new pellet formulation

1 outlet · first reported by FDA Drug Safety / Drugs feed 1d ago

Coverage, in order

  1. 1d ago
    FDA expands pediatric indication for entrectinib and approves new pellet formulation

    On October 20, 2023, the Food and Drug Administration granted accelerated approval to entrectinib (Rozlytrek, Genentech Inc.) for pediatric patients older than 1 month with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation,

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