FDA expanded pediatric use of entrectinib, cleared new pellet formulation
The agency granted accelerated approval for entrectinib in younger children with NTRK fusion-positive solid tumors and authorized a new dosage form.
On October 20, 2023, the Food and Drug Administration granted accelerated approval to entrectinib, marketed as Rozlytrek by Genentech Inc., expanding its use to 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.1
Alongside the expanded pediatric indication, the FDA approved a new pellet formulation of the drug.
The approval record does not provide additional detail on the trial data supporting this decision, the specific endpoints measured, or the accelerated approval's confirmatory trial requirements. Readers seeking those specifics should consult the full FDA prescribing information and any related clinical trial documentation, as this summary reflects only what is stated in the agency's announcement.
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