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meRfi® Microbiome - The Digital Gut Microbiome Reference (incl. AI Chat)
Prebiotics, Probiotics, FMT / Manipulators of the Intestinal Microbiota

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Entrectinib & NTRK-fusion Tumors

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Approval status

FDA: Entrectinib (Rozlytrek TM) - accelerated approval for unresectable/metastatic or high-morbidity NTRK fusion-positive solid tumors; adults and pediatric patients, now including those older than 1 month (1)
EMA: Entrectinib (Rozlytrek) - EU authorization for NTRK fusion-positive solid tumors; initially 12 years and older, with later extension process supporting use in patients older than 1 month (2)

References

(1) Marcus et al. 2021 Clin Cancer Res 27(4): 928-932
(2) [Rozlytrek | European Medicines Agency (E…

References (Sources)

FDA Approval Summary: Entrectinib for the Treatment of NTRK gene Fusion Solid Tumors
Marcus et al. 2021 Clin Cancer Res 27(4): 928-932

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7/1/2026

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