What is Alunbrig (brigatinib) for?
Alunbrig (brigatinib) is indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who are intolerant to crizotinib, or who experienced the progression of their disease during or after the treatment with crizotinib1. Crizotinib is a drug for ALK-positive NSCLC widely approved (e.g. in USA by FDA2 and in Europe by EMA3).
How does Alunbrig (brigatinib) work?
The ALK (anaplastic lymphoma kinase) gene plays an important role in the development of the brain and exerts its effects on specific neurons in the nervous system4. Mutations of the ALK gene can occur in several different types of cells, including lung cells, and can result in the development of a tumour2. ALK gene mutations occur in 3 to 7% of patients with NSCLC5.
Patients who have advanced ALK-positive NSCLC are generally highly responsive to ALK inhibitor crizotinib5,6. However, almost all patients treated with crizotinib experience progression of their disease, which results in the development of secondary ALK mutations that are resistant to this therapeutics. Approximately 40% of the ALK-positive NSCLC patients develop metastases in their central nervous system (brain and spinal cord), as an initial site of progression5,6.
Similarly to crizotinib and alectinib, brigatinib is an ALK-inhibitor, which acts by inhibiting the activity of the ALK protein, and may prevent ALK-positive NSCLC-cells from growing and spreading7. Alunbrig (brigatinib) offers an additional option to patients who developed resistance to crizotinib.
Is Alunbrig (brigatinib) approved?
Alunbrig (brigatinib) was approved for patients with ALK+ metastatic NSCLC who have progressed on or are intolerant to crizotinib7, by:
Food and Drug Administration (FDA) (US) on April 28, 2017.
How do I take Alunbrig (brigatinib)?
The standard dosage for Alunbrig (brigatinib) is:
90 mg orally once daily for the first 7 days
if tolerated, increase to 180 mg orally once daily.
Administer Alunbrig (brigatinib) until disease progression or unacceptable toxicity. If the dose is not tolerated, the recommended dose reduction levels can be found in the prescribing information1.
Complete information about Alunbrig (brigatinib) dosage and administration can be found in the resources section1.
Note: Consult your treating doctor for personalised dosing.
Are there any known adverse reactions or side effects of Alunbrig (brigatinib)?
Common adverse reactions
The most common adverse reactions listed in the prescribing information include1:
nausea
diarrhea
fatigue
cough
headache.
Serious adverse reactions
The serious adverse reactions listed in the prescribing information include1:
interstitial lung disease (ILD)/pneumonitis
hypertension (high blood pressure)
bradycardia (slow heart rate)
visual disturbances
pancreatic enzyme elevation
hyperglycemia
Use in specific population
Alunbrig (brigatinib) can be fatal for a fetus, it is advised to avoid pregnancies and breastfeeding.
For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information1.