Alecensa (alectinib)

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Alecensa (alectinib)

How to buy Alecensa (alectinib): You can order Alecensa (alectinib) 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 Roche
Disease Lung Cancer
Indication ALK-positive NSCLC
Mode of Action ALK inhibitor (targeted therapy)
Approval Status EMA approved (EU); FDA approved (USA); PMDA approved (JAP); TGA approved (AUS)
CAS Number 1256580-46-7
HS Code 29349990
Strength 150 mg

Who is Alecensa (alectinib) for?

Alecensa (alectinib) is indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant of crizotinib [1], a drug for ALK-positive NSCLC widely approved (e.g. in USA by the FDA [2] and in Europe by the EMA [3]).
On October 12, 2017, the European Committee for Medicinal Products for Human Use (CHMP) recommended a change to the terms of the marketing authorisation by extending the indication of alectinib as monotherapy for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) [16].

Alecensa (alectinib) recommended dose

Complete information about Alecensa (alectinib) dosage and administration can be found here [1][13][14].
The standard dosage is:
  • 600 mg (4 150 mg capsules) orally twice daily. Administer Alecensa (alectinib) with food
Consult your treating doctor for personalised dosing.

What is Alecensa (alectinib) and how does it work?

Alecensa (alectinib) is an oral therapeutic for advanced (metastatic) ALK-positive non-small cell lung cancer (NSCLC). It is a new option for patients whose disease has worsened after crizotinib, or who could not tolerate it in the first place [2].
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 [6]. 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 [7]. Patients who have advanced ALK-positive NSCLC are generally highly responsive to ALK inhibitor crizotinib [7][8]. However, almost all patients treated with crizotinib experience progression of their disease, developing 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 [7][8].
Similarly to crizotinib, alectinib is an ALK-inhibitor, which acts by inhibiting the activity of the ALK protein, and may thus prevent ALK-positive NSCLC-cells from growing and spreading [2]. Crizotinib and alectinib target different mutations of the ALK-gene [7]; the latter might thus prove effective when the former starts failing. Alectinib’s inhibiting action was indeed observed in ALK gene mutations resistant to crizotinib [8]. Furthermore, while crizotinib is blocked by the brain’s defensive barrier [7][9], alectinib demonstrated its ability to penetrate the CNS and its shrinking effect on brain metastases [7][8].

What is Alecensa's (alectinib) approval status?

Alecensa (alectinib) was approved by
  • PMDA (Japan) in July 2014 [10]
  • FDA (USA) on December 11, 2015 [2]
  • EMA (EU) on February 21, 2017 [12]
  • TGA (AUS) on March 14, 2017 [13]
for ALK (anaplastic lymphoma kinase)-positive non-small cell lung cancer (NSCLC), in patients whose disease had worsened after—or who could not tolerate—treatment with crizotinib [2][12][13].
On October 12, 2017, the European Committee for Medicinal Products for Human Use (CHMP) recommended a change to the terms of the marketing authorisation by extending the indication of alectinib as monotherapy for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) [16].
The PMDA approval was partly based on a study which included 46 patients and demonstrated a response rate of 93.5 % (95 % CI: 82.1 - 98.6 %) with a progression free survival at 12 months in 83 % (95 % CI: 68 - 92 %) of the patients [10].
The FDA, EMA, and TGA approvals were based on two studies (NP28673 and NP28761) that returned positive results [1][12][4][13]. In the first study, which included 87 participants, 38 % (95 % CI: 28, 49) of participants experienced a partial shrinkage of their NSCLC tumours—an effect that lasted for an average of 7.5 months (95 % CI: 4.9, non-estimable) [1][4]. The median progression-free survival (PFS) for people who received alectinib was 8.9 months [4]. In the second study, which included 138 participants, 44 % of participants experienced a partial shrinkage of their NSCLC tumours, lasting for an average of 11.2 months. The trials also examined alectinib’s effect on individuals’ brain metastases, a common occurrence in this population. About 60 % of participants in the two trials who had measurable brain metastases experienced a complete or partial reduction in their brain tumours, lasting an average of 9.1 months [5][2].
Among the most common adverse reactions were fatigue, constipation, oedema and myalgia (muscle pain) [1][13][14].
Recently a study (ALEX) which involved 303 untreated patients, compared alectinib with crizotinib. It resulted that alectinib reduced the risk of death by 53 % compared to crizotinib when given as initial treatment (first-line) for ALK+ NSCLC. The median PFS assessed by an independent review commitee (IRC) was 25.7 months (95% CI: 19.9, not reached) versus 10.4 months (95% CI: 7.7, 14.6) for people treated with crizotinib [11][15].
References
[1] Summary of Product Characteristics [FDA]: Alecensa (alectinib), Roche Ltd., Dec. 2015.
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208434s000lbl.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 18/01/2016.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002489/human_med_001592.jsp&mid=WC0b01ac058001d124
[4] Roche Media Release: Roche’s investigational medicine alectinib shrank tumours in nearly half of people with specific type of lung cancer, 14/05/2015.
http://www.roche.com/media/store/releases/med-cor-2015-05-14.htm
[5] Roche Media Release: FDA grants Roche’s Alecensa (alectinib) accelerated approval for people with a specific type of lung cancer, 14/12/2015.
http://www.roche.com/med-cor-2015-12-14-e.pdf
[6] Gene Cards. ALK Gene (Protein Coding).
http://www.genecards.org/cgi-bin/carddisp.pl?gene=ALK
[7] M.M. Awad and A.T. Shaw. 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
[8] S.H.I. Ou, 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
[9] T. Kodama, et al. Antitumor activity of the selective ALK inhibitor alectinib in models of intracranial metastases. Cancer Chemother Pharmacol. 2014 Nov; 74(5);1023-1028.
http://link.springer.com/article/10.1007%2Fs00280-014-2578-6
[10] Roche Media Release: Japan becomes first country to approve Roche's alectinib for people with a specific form of advanced lung cancer, 04/07/2015.
http://www.roche.com/media/store/releases/med-cor-2014-07-04.htm
[11] ClinicalTrials.gov. A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants (ALEX), 27/02/2014 (last update: 23/02/2017), cited on 18/01/2016.
https://clinicaltrials.gov/ct2/show/NCT02075840
[12] Roche Media Release: Roche receives EU approval of Alecensa (alectinib) for people with previously treated ALK-positive non-small cell lung cancer, 21/02/2017.
http://www.roche.com/media/store/releases/med-cor-2017-02-21.htm
[13] Summary of Product Characteristics [TGA]: Alecensa (alectinib), Roche Ltd., Mar. 2017.
https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2017-PI-01495-1&d=2017102316114622483
[14] Summary of Product Characteristics [EMA]: Alecensa (alectinib), Roche Ltd., Apr. 2017.
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004164/WC500225707.pdf
[15] Roche Media Release: Phase III study showed Roche’s Alecensa (alectinib) reduced the risk of disease progression or death by more than half versus crizotinib as first-line treatment in a specific type of lung cancer, 05/06/2017.
http://www.roche.com/media/store/releases/med-cor-2017-06-05b.htm
[16] EMA / CHMP: Summary of opinion - Alecensa (alectinib), 12/10/2017.
http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion/human/004164/WC500236608.pdf

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.

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