Alunbrig (brigatinib)

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Alunbrig (brigatinib)

How to buy Alunbrig: You can order Alunbrig (brigatinib) via TheSocialMedwork if the drug has not been approved and/or is not available in the patient's country. TheSocialMedwork - helping patients and doctors access the latest approved medicines and at the lowest price possible worldwide.

Manufacturer ARIAD Pharmaceuticals
Disease Lung Cancer
Indication ALK-positive NSCLC
Mode of Action ALK inhibitor (targeted therapy)
Approval Status FDA approved (USA)
CAS Number 1256580-46-7
HS Code 29349990
Strength 30 mg

Who is 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 crizotinib [1]. Crizotinib is a drug for ALK-positive NSCLC widely approved (e.g. in USA by FDA [2] and in Europe by EMA [3]).

Recommended dose

Complete information about Alunbrig (brigatinib) dosage and administration can be found here: [1].
The standard dosage is:
  • 90 mg orally once daily for the first 7 days;
  • if tolerated, increase to 180 mg orally once daily.
Administer brigatinib until disease progression or unacceptable toxicity. If the dose is not tolerated, the recommended dose reduction levels can be found in the prescribing information: [1].
Consult your treating doctor for personalised dosing.

What is brigatinib and how does it work?

Alunbrig (brigatinib) is a kinase inhibitor used to treat adults 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 crizotinib.
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 system [4]. Mutations of the ALK  gene can occur in several different types of cells, including lung cells, and can result in the development of a tumour [2]. ALK gene mutations occur in 3 to 7 % of patients with NSCLC [5].
Patients who have advanced ALK-positive NSCLC are generally highly responsive to ALK inhibitor crizotinib [5][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 progression [5][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 spreading [7]. Alunbrig (brigatinib) offers an additional option to patients who developed resistance to crizotinib.

What is brigatinib's approval status?

Alunbrig (brigatinib) was approved by:
  • FDA (US) on April 28, 2017
for patients with ALK+ metastatic NSCLC who have progressed on or are intolerant to crizotinib [7].
The approval was based on a study (ALTA) involving 222 patients with locally advanced or metastatic ALK+ NSCLC who had progressed on crizotinib. 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 months [7].
References
[1] Summary of Product Characteristics [FDA]: Alunbrig (brigatinib), ARIAD Pharmaceuticals Inc., Apr. 2017.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208772lbl.pdf
[2] FDA News Release: FDA approves new oral therapy to treat ALK-positive lung cancer, 11/12/2015.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm476926.htm
[3] EMA. Human Medicines: Xalkori (crizotinib), 14/11/2012 (last update: 13/01/2017), cited on 15/06/2017.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002489/human_med_001592.jsp&mid=WC0b01ac058001d124
[4] Gene Cards. ALK Gene (Protein Coding).
http://www.genecards.org/cgi-bin/carddisp.pl?gene=ALK
[5] Awad M.M. and Shaw A.T.. ALK inhibitors in non–small cell lung cancer: crizotinib and beyond. Clin Adv Hematol Oncol. 2014 Jul; 12(7):429-39.
https://www.ncbi.nlm.nih.gov/pubmed/25322323
[6] Ou S.H.I., et al. Alectinib in crizotinib-refractory ALK-rearranged non–small-cell lung cancer: a phase II global study. J Clin Oncol. 2016 Mar; 34(7):661-668.
http://jco.ascopubs.org/content/early/2016/01/07/JCO.2015.63.9443?cmpid=jco_pap_11Jan2016
[7] Drugs.com. FDA Approves Alunbrig, 28/04/2017, cited on 14/06/2017.
https://www.drugs.com/newdrugs/takeda-announces-fda-accelerated-approval-alunbrig-brigatinib-4527.html?utm_source=ddc&utm_medium=email&utm_campaign=Takeda+Announces+FDA+Accelerated+Approval+of+Alunbrig+%28brigatinib%29








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