Anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC)

Active Ingredient: Brigatinib

Indication for Brigatinib

Population group: only adults (18 years old or older)

Brigatinib is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor.

Brigatinib is indicated as monotherapy for the treatment of adult patients with ALK-positive advanced NSCLC previously treated with crizotinib.

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

90-180 mg once daily

Route of admnistration


Defined daily dose

90 - 180 mg

Dosage regimen

From 90 To 180 mg once every day

Loading dose

90 mg

Maintenance dose

180 mg

Detailed description

The recommended starting dose of brigatinib is 90 mg once daily for the first 7 days, then 180 mg once daily.

If brigatinib is interrupted for 14 days or longer for reasons other than adverse reactions, treatment should be resumed at 90 mg once daily for 7 days before increasing to the previously tolerated dose.

If a dose is missed or vomiting occurs after taking a dose, an additional dose should not be administered and the next dose should be taken at the scheduled time. Treatment should continue as long as clinical benefit is observed.

Dose adjustments

Dosing interruption and/or dose reduction may be required based on individual safety and tolerability.

Brigatinib dose reduction levels are summarised in Table 1.

Table 1. Recommended brigatinib dose reduction levels:

DoseDose reduction levels
90 mg once daily (first 7 days) reduce to 60 mg once dailypermanently discontinuenot applicable
180 mg once dailyreduce to 120 mg once dailyreduce to 90 mg once dailyreduce to 60 mg once daily

Brigatinib should be permanently discontinued if patient is unable to tolerate the 60 mg once daily dose.

Recommendations for dose modifications of brigatinib for the management of adverse reactions are summarised in Table 2.

Table 2. Recommended brigatinib dose modifications for adverse reactions:

Dosage considerations

Brigatinib may be taken with or without food.

Grapefruit or grapefruit juice may increase plasma concentrations of brigatinib and should be avoided.

Active ingredient

Brigatinib is a tyrosine kinase inhibitor that targets ALK, c-ros oncogene 1 (ROS1), and insulin-like growth factor 1 receptor (IGF-1R). It is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).

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