Alecensa (alectinib)

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Alecensa (alectinib)

How to buy Alecensa: 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 alectinib for?

Alectinib is indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) [1]. An FDA approved test can be used to confirm the type of lung cancer [17].

Alectinib was at first approved for patients who have progressed on or are intolerant of crizotinib [2], 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]. The FDA approved it as first-line treatment for ALK-positive NSCLC in November 2017 [17].

Recommended dose

Complete information about 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 alectinib with food.
Consult your treating doctor for personalised dosing.

What is alectinib and how does it work?

Alectinib is a first-line oral therapeutic for advanced (metastatic) ALK-positive non-small cell lung cancer (NSCLC) [1]

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 therapeutic. 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 may 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]. Recent studies have shown that alectinib extended the average time that people lived without their disease worsening compared to crizotinib [17].

What is alectinib’s approval status?

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]. In November 2017 the FDA extended its approval to the use as first-line treatment for ALK-positive NSCLC [17].
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 FDA approval on previously untreated ALK-positive NSCLC was based on a study (ALEX [11]) which involved 303 patients who had not been previously treated for metastatic disease, and 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 [15]. The median progression-free survival (PFS) was 25.7 months (95% CI: 19.9, not reached) in patients treated with alectinib versus 10.4 months (95% CI: 7.7, 14.6) for people treated with crizotinib [1]. Complete response was achieved in 13 % of patients treated with alectinib vs. 6 % of those treated with crizotinib. After 18 months 37 % of patients in the alectinib's cohort were still in response, compared with 14 % of those in the crizotinib's cohort. The objective response rate on brain metastases was 81 % (38 % complete response) in the group treated with alectinib and 50 % (5 % complete response) in the group treated with crizotinib [1].

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 for previously treated ALK-positive NSCLC 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, both in first and second line treatment, were fatigue, constipation, oedema and myalgia (muscle pain) [1][13][14].
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









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