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Lung Oncology Pregnancy: Contraindicated — embryofetal toxicity; effective contraception during and for 6 weeks after treatment

Osimertinib

Brand names: Tagrisso

Adult dose

Dose: 80 mg once daily
Route: Oral
Frequency: Once daily
Max: 80 mg/day (160 mg if co-administered with strong CYP3A4 inducers)
Third-generation EGFR TKI — irreversible inhibitor. Active against EGFR exon 19 deletions, exon 21 L858R substitution, and T790M resistance mutation. CNS penetration superior to 1st/2nd gen TKIs.

Paediatric dose

Route: Oral
Seek specialist opinion — not licensed in children

Dose adjustments

Renal

No dose adjustment required for mild-moderate renal impairment; caution in severe renal impairment

Hepatic

No dose adjustment for mild impairment; caution in moderate-severe hepatic impairment

Clinical pearls

  • FLAURA trial (Soria et al. NEJM 2018): osimertinib first-line vs gefitinib/erlotinib — mPFS 18.9 vs 10.2 months; OS benefit confirmed. Standard first-line for EGFR-mutant NSCLC.
  • ADAURA trial: adjuvant osimertinib after resection of EGFR+ NSCLC — 80% reduction in disease recurrence at 2 years
  • LAURA trial 2024: maintenance osimertinib after chemoradiotherapy in stage III unresectable EGFR+ NSCLC — significant PFS benefit
  • CNS metastases: osimertinib crosses BBB effectively — CNS response rate ~90% for T790M+ brain mets
  • Pneumonitis: grade 2 — hold; grade 3-4 — discontinue permanently

Contraindications

  • Pregnancy (embryofetal toxicity)
  • Concomitant St John's Wort
  • Hypersensitivity

Side effects

  • Diarrhoea
  • Rash (acneiform)
  • Dry skin/paronychia
  • Stomatitis
  • QTc prolongation
  • Pneumonitis (1.7%)
  • Cardiomyopathy/LVEF reduction
  • Venous thromboembolism

Interactions

  • Strong CYP3A4 inducers (rifampicin, phenytoin, carbamazepine) — reduce exposure; increase dose to 160 mg if unavoidable
  • QTc-prolonging drugs
  • Warfarin — monitor INR

Monitoring

  • EGFR mutation status
  • LVEF at baseline and during treatment
  • LFTs
  • ECG/QTc
  • Chest imaging if respiratory symptoms

Reference: BNFc; BNF 90; FLAURA Trial (Soria et al. NEJM 2018); ADAURA Trial (Wu et al. NEJM 2020); NICE TA654; SPC Tagrisso. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.

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