Non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations

Active Ingredient: Osimertinib

Indication for Osimertinib

Population group: only adults (18 - 65 years old)

Osimertinib as monotherapy is indicated for:

  • the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations.
  • the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC.

For this indication, competent medicine agencies globally authorize below treatments:

80 mg once a day

Route of admnistration

Oral

Defined daily dose

80 - 80 mg

Dosage regimen

From 80 To 80 mg once every day

Detailed description

The recommended dose is 80 mg osimertinib once a day until disease progression or unacceptable toxicity.

If a dose of osimertinib is missed, the dose should be made up unless the next dose is due within 12 hours.

Dose adjustments

Dosing interruption and/or dose reduction may be required based on individual safety and tolerability. If dose reduction is necessary, then the dose should be reduced to 40 mg taken once daily.

Dose reduction guidelines for adverse reactions toxicities are provided in th following table.

Recommended dose modifications for osimertinib:

Target organ Adverse reactiona Dose modification
Pulmonary ILD/Pneumonitis Discontinue osimertinib
Cardiac QTc interval greater than 500 msec on at least 2 separate ECGsWithhold osimertinib until QTc interval is less than 481 msec or recovery to baseline if baseline QTc is greater than or equal to 481 msec, then restart at a reduced dose (40 mg)
QTc interval prolongation with signs/symptoms of serious arrhythmiaPermanently discontinue osimertinib
Other Grade 3 or higher adverse reaction Withhold osimertinib for up to 3 weeks
If Grade 3 or higher adverse reaction improves to Grade 0-2 after withholding of osimertinib for up to 3 weeksosimertinib may be restarted at the same dose (80 mg) or a lower dose (40 mg)
Grade 3 or higher adverse reaction that does not improve to Grade 0-2 after withholding for up to 3 weeksPermanently discontinue osimertinib

a Note: The intensity of clinical adverse events graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
ECGs: Electrocardiograms; QTc: QT interval corrected for heart rate

Dosage considerations

Osimertinib can be taken with or without food at the same time each day.

Active ingredient

Osimertinib

Osimertinib is a Tyrosine Kinase Inhibitor (TKI). It is an irreversible inhibitor of Epidermal Growth Factor Receptors (EGFRs) harboring sensitising-mutations (EGFRm) and TKI-resistance mutation T790M. In vitro studies have demonstrated that osimertinib has high potency and inhibitory activity against EGFR across a range of all clinically relevant EGFR sensitising-mutant and T790M mutant non-small cell lung cancer (NSCLC) cell lines.

Read more about Osimertinib

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