Active Ingredient: Lazertinib
Lazertinib in combination with amivantamab is indicated for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 240 milligrams lazertinib, once daily.
The recommended dose of lazertinib is 240 mg once daily in combination with amivantamab.
It is recommended to administer lazertinib any time prior to amivantamab when given on the same day.
At the initiation of treatment, prophylactic anticoagulants should be administered to prevent venous thromboembolic (VTE) events in patients receiving lazertinib in combination with amivantamab. Consistent with clinical guidelines, patients should receive prophylactic dosing of either a direct acting oral anticoagulant (DOAC) or a low molecular weight heparin (LMWH). Use of Vitamin K antagonists is not recommended.
Patients should be instructed to limit sun exposure during and for 2 months after lazertinib combination therapy and alcohol-free emollient cream is recommended for dry areas.
Treatment should continue until disease progression or unacceptable toxicity.
If a planned dose of lazertinib is missed, it can be administered within 12 hours. If more than 12 hours have passed since the dose was to be given, the missed dose should not be administered and the next dose should be administered per the usual dosing schedule.
The recommended dose reductions for adverse reactions are presented in the following table.
Recommended lazertinib dose reductions for adverse reactions:
| Dose reduction | Recommended dose |
|---|---|
| Initial dose | 240 mg once daily |
| 1st dose reduction | 160 mg once daily |
| 2nd dose reduction | 80 mg once daily |
| 3rd dose reduction | Discontinue lazertinib |
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