FDA — authorised 5 November 2021
- Application: NDA212725
- Marketing authorisation holder: GENENTECH INC
- Indication: Labeling
- Status: approved
🇺🇸 ENTRECTINIB in United States
FDA authorised ENTRECTINIB on 5 November 2021 · 357 US adverse-event reports
Marketing authorisations
FDA — authorised 20 October 2023
- Application: NDA218550
- Marketing authorisation holder: GENENTECH INC
- Indication: Type 3 - New Dosage Form
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 357
Most-reported reactions
- Disease Progression — 61 reports (17.09%)
- Off Label Use — 54 reports (15.13%)
- Drug Ineffective — 48 reports (13.45%)
- Dizziness — 39 reports (10.92%)
- Pancytopenia — 32 reports (8.96%)
- Metastases To Central Nervous System — 28 reports (7.84%)
- Renal Impairment — 28 reports (7.84%)
- Blood Creatinine Increased — 24 reports (6.72%)
- Taste Disorder — 22 reports (6.16%)
- Nausea — 21 reports (5.88%)
ENTRECTINIB in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is ENTRECTINIB approved in United States?
Yes. FDA authorised it on 5 November 2021; FDA authorised it on 20 October 2023.
Who is the marketing authorisation holder for ENTRECTINIB in United States?
GENENTECH INC holds the US marketing authorisation.