Alunbrig (brigatinib)

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Alunbrig (brigatinib)

How to buy Alunbrig (brigatinib): You can order Alunbrig (brigatinib) from TheSocialMedwork if the drug has not been approved or is not available in your country. We help patients and doctors get access to medicines at the lowest price worldwide.

Oncology Lung Cancer
Marketing Authorisation Holder ARIAD Pharmaceuticals, Inc.
Mode of Action ALK inhibitor (targeted therapy)
Administration Oral
Regulatory agency approval Food and Drug Administration (FDA), USA

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 side effects of Alunbrig (brigatinib)?

Common side effects

The most common side effects listed in the prescribing information include1:

  • nausea
  • diarrhea
  • fatigue
  • cough
  • headache.

Serious side effects

The serious side effects 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.

More Information
Working ingredient brigatinib
Shipping method Controlled room temperature (temperature controlled)
Therapeutic Area Oncology
Oncology Lung Cancer
Indication Anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC)
Administration Oral
Mode of Action ALK inhibitor (targeted therapy)
Regulatory agency approval Food and Drug Administration (FDA), USA
Marketing Authorisation Holder ARIAD Pharmaceuticals, Inc.
HS Code N/A
CAS Number N/A

Approval of Alunbrig (brigatinib) was based on a study (ALTA) involving 222 patients with locally advanced or metastatic ALK+ NSCLC who had progressed on crizotinib7,1.

Results

  • The overall response rate was 53% [95% CI: 43, 62] with 4.5% complete response rate (as assessed by an Independent Review Committee (IRC)), and the median duration of response was 13.8 months [95% CI: 5.6, 13.8] as assessed by an IRC.
  • Additionally, 67% [95% CI: 41, 87] of patients with measurable brain metastases achieved a confirmed intracranial overall response which lasted about 6 months7,1.

1.Summary of Product Characteristics [FDA]: Alunbrig (brigatinib) [PDF]
   ARIAD Pharmaceuticals Inc., fda.gov, Apr 2017.

2. FDA News Release: FDA approves new oral therapy to treat ALK-positive lung cancer
    fda.gov, December 2015.

3.EMA. Human Medicines: Xalkori (crizotinib)
   ema.europa.eu, cited June 2017

4. Gene Cards. ALK Gene (Protein Coding)
    genecards.org

5. ALK inhibitors in non–small cell lung cancer: crizotinib and beyond
    Clin Adv Hematol Oncol. Awad M.M. and Shaw A.T., July 2014

6. Alectinib in crizotinib-refractory ALK-rearranged non–small-cell lung cancer: a phase II global study
    J Clin Oncol. March 2016

7.Drugs.com. FDA Approves Alunbrig
   cited June 2017

Shipping Type Cold Chain
Shipping method Controlled room temperature (temperature controlled)
Dynamic Weight No
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Patient reviews

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Medicine information contained herein may be time sensitive. The absence of a warning for a given medicine or combination thereof in no way should be construed to indicate that the medicine or combination is safe, effective or appropriate for any given patient. Always consult your treating physician before starting a course of treatment.