Do you mean clinical data, dosing and safety, or something else about Tagrisso (osimertinib)? Here’s a concise overview to cover the main data you might be after. If you want specific numbers or a particular trial, tell me and I’ll pull those.
What Tagrisso is
- Osimertinib, a third-generation EGFR tyrosine kinase inhibitor (TKI) used for EGFR-mutant non-small cell lung cancer (NSCLC).
Approved indications (US)
- Metastatic EGFR-mutant NSCLC (exon 19 deletion or L858R) as first-line therapy.
- EGFR T790M mutation-positive NSCLC after progression on prior EGFR-TKI therapy (second-line or later).
- Adjuvant setting: Stage IB-IIIA EGFR-mutant NSCLC after complete surgical resection.
Typical dosing
- 80 mg taken orally once daily, with or without food.
- If using a strong CYP3A4 inhibitor, dose reduction to 40 mg once daily is recommended; avoid concomitant strong inhibitors if possible. If inhibitor is stopped, osimertinib can be resumed at 80 mg daily (per label guidance).
- If strong CYP3A4 inducers are used, consider alternatives if possible (drug interactions can affect exposure).
What the major trials show (high-level)
- First-line EGFR-mutant NSCLC (FLAURA): Osimertinib improves progression-free survival and overall survival versus standard first-generation EGFR-TKIs.
- T790M-positive after progression on a prior EGFR-TKI (AURA3): Osimertinib improves progression-free survival vs chemotherapy.
- Adjuvant setting (ADAURA): Osimertinib after surgical resection improves disease-free survival in Stage IB-IIIA EGFR-mutant NSCLC.
- CNS activity: Osimertinib has meaningful activity against brain metastases, which is a notable advantage over some earlier EGFR-TKIs.
Common and serious adverse events
- Common (usually mild to moderate): rash, diarrhea, dry skin, stomatitis, decreased appetite, fatigue.
- Serious but less common: interstitial lung disease/pneumonitis, QT prolongation, potential cardiomyopathy.
- Other notes: ocular/eye-related effects can occur; monitor for symptoms and have baseline and periodic assessments as advised by your oncologist.
Key safety/monitoring points
- Baseline and periodic liver function tests, electrolytes, and ECG as indicated.
- Watch for new/worsening shortness of breath, cough, chest pain (possible pneumonitis or heart-related effects).
- Avoid or carefully manage concomitant medicines that are strong CYP3A4 inhibitors or inducers.
Where to find the primary data
- FDA prescribing information (Tagrisso): dosing, indications, safety, drug interactions.
- Major trials:
- FLAURA (first-line): JELINE/NEJM publication details in 2019-2020.
- AURA3 (second-line): NEJM publication details.
- ADAURA (adjuvant): NEJM publication details.
- Real-world data and guidelines: oncology society guidelines (ASCO, NCCN) and EU/EMA product information.
If you can specify what you want (e.g., exact trial numbers and numerical results, dosing for a specific scenario, management of a drug interaction, or a patient-friendly summary), I can pull the precise data or format it (tables/summary) for you.