Alecensa (alectinib)

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Alecensa (alectinib)

Alecensa (alectinib) is a medication used for the treatment of anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC).

How to buy Alecensa (alectinib): You can order Alecensa (alectinib) from TheSocialMedwork if the drug has not been approved or is not available in your country. 

For this product the estimated delivery time is usually between 5 and 10 working days.

Oncology Lung Cancer
Marketing Authorisation Holder Roche Registration GmbH
Mode of Action ALK inhibitor (targeted therapy)
Administration Oral
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA, Pharmaceuticals and Medical Devices Agency (PMDA), Japan, Therapeutic Goods Administration (TGA), Australia
Strength 150 milligram
Package 224 Capsules

What is Alecensa (alectinib)?

Alecensa (alectinib) is an oral therapeutic for advanced (metastatic) ALK-positive non-small cell lung cancer (NSCLC)1,13,14.

Who is Alecensa (alectinib) for?

Alecensa (alectinib) is indicated for the treatment of people with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC). It was initially approved as a new option for patients whose disease has worsened after crizotinib or who could not tolerate it in the first place2,10,12,13. (Crizotinib is a drug for ALK-positive NSCLC widely approved, e.g. in USA by the Food and Drug Administration (FDA)2 and in Europe by the European Medical Agency (EMA)3).

Recently the approval has been extended to include the treatment of patients whose disease has not been treated yet (first-line treatment)1,13,14,16.

How does Alecensa (alectinib) work?

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 spreading2. Crizotinib and alectinib target different mutations of the ALK-gene7; the latter might thus prove effective when the former starts failing. Alectinib’s inhibiting action was observed in ALK gene mutations resistant to crizotinib8. Furthermore, while crizotinib is blocked by the brain’s defensive barrier7,9, alectinib demonstrated its ability to penetrate the central nervous system (CNS, brain and spinal cord) and its shrinking effect on brain metastases7,8.

Approximately 40% of the ALK-positive NSCLC patients develop metastases in their CNS, as an initial site of progression7,8. 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 system6. 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 NSCLC7.

Where has Alecensa (alectinib) been approved?

Alecensa (alectinib) was approved for ALK (anaplastic lymphoma kinase)-positive non-small cell lung cancer (NSCLC) by:

  • Pharmaceuticals and Medical Devices Agency (PMDA), Japan, July 201410— second-line after crizotinib

  • Food and Drug Administration (FDA), USA, December 11, 20152 — first-line treatment since November 201716

  • European Medical Agency (EMA), European Union, February 21, 201712 — first-line treatment since January 201817

  • Therapeutic Goods Administration (TGA), Australia, March 14, 201713— first-line treatment since January 2018.

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Alecensa (alectinib) taken?

The standard dosage is1,13,14:

  • 600 mg (4 150 mg capsules) orally twice daily.

Administer Alecensa (alectinib) with food.

Administer until disease progression or unacceptable toxicity.

Complete information about Alecensa (alectinib) dosage and administration can be found in the resources guide below1,13,14.

Note: Please consult your treating doctor for personalised dosing.

Are there any known adverse reactions or side effects of Alecensa (alectinib)?

Common adverse reactions

The most common side effects listed in the prescribing information include1,13,14:

  • fatigue (tiredness)

  • constipation

  • oedema (accumulation of fluids)

  • myalgia (muscle pain)

  • anemia (lack of red blood cells).

Serious adverse reactions

The serious adverse reactions listed in the prescribing information include1,13,14:

  • hepatotoxicity (drug-induced liver injury)

  • interstitial lung disease (ILD)/pneumonitis

  • renal impairment (kidney failure)

  • bradycardia (slow heart rate)

  • severe myalgia (muscle pain) and creatine phosphokinase (CPK) elevation (muscle tissue injury).

Use in specific population

Alecensa (alectinib) could cause fetal harm when administered to a pregnant woman. Alecensa (alectinib) should not be used during pregnancy and breastfeeding is not advised1,13,14.


For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information1,13,14.

More Information
Working ingredient alectinib
Shipping method Standard (not temperature controlled)
Length (cm) 19
Width (cm) 14
Height (cm) 16
Package 224
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 European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA, Pharmaceuticals and Medical Devices Agency (PMDA), Japan, Therapeutic Goods Administration (TGA), Australia
Marketing Authorisation Holder Roche Registration GmbH
HS Code 29349990
CAS Number 1256580-46-7

1st line treatment approval

The approvals from the Food and Drug Administration (FDA), USA, European Medical Agency (EMA), European Union, Therapeutics Goods Administration (TGA), Australia, as first-line treatment were based on a phase III study (ALEX). This study involved 303 untreated patients and compared alectinib with crizotinib1,13,14.

Results

Among the efficacy outcome measures was the median time from disease progression (progression-free survival - PFS). Among other measures, the efficacy on the brain lesions was measured as the overall response rate in the central nervous system (CNS-ORR) in patients with measurable CNS metastases at baseline1,113,14.

Alecensa (alectinib) resulted in PFS more than two-fold longer and remarkable responses in brain lesions1,13,14.

The median PFS was 1,13,14:

  • 25.7 months [95% CI: 19.9, not reached] with Alecensa (alectinib)

  • 10.4 months [95% CI: 7.7, 14.6] with crizotinib.

The CNS-ORR was1,13,14:

  • 81% [95% CI: 58, 95] with Alecensa (alectinib)

    • 38% complete responses (CR).

  • 50% [95% CI: 28, 72] with crizotinib

    • 5% CR.

2nd-line treatment approval

The Food and Drug Administration (FDA), USA, European Medical Agency (EMA), European Union, and Therapeutic Goods Administration (TGA), Australia, approvals of Alecensa (alectinib) as second-line treatment were based on two single arm (without comparator) studies (NP28673 and NP28761) that returned positive results1,13,14. Study NP28673 involved 87 participants while NP28761 involved 138 patients.

Results

Among the efficacy outcome measures were the objective response rate (ORR) and duration of response (DOR) altogether and in the brain (central nervous system, CNS).

The ORR was1:

  • 38% [95% CI: 28, 49] in Study NP28761

  • 44% [95% CI: 36, 53] in Study NP28673.

The DOR was1:

  • 7.5 months [95% CI: 4.9, non-estimable] in Study NP28761

  • 11.2 months [95% CI: 9.6, non-estimable] in Study NP28673.

The CNS-ORR was1:

  • 61% [95% CI: 46, 74] in Study NP28761 and Study NP28673

  • 18% complete responses.

The CNS-DOR was1:

  • 9.1 months [95% CI: 5.8, non-estimable] in Study NP28761and Study NP28673.

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 PFS at 12 months in 83% (95% CI: 68 - 92) of the patients10.

  1. Summary of Product Characteristics [FDA]: Alecensa (alectinib), [PDF]
    Roche Ltd., Nov 2017.

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

  3. EMA. Human Medicines: Xalkori (crizotinib)
    ema.europe.eu, updated Jan 2016,cited on 18/01/2016.

  4. Roche Media Release: Roche’s investigational medicine alectinib shrank tumours in nearly half of people with specific type of lung cancer,
    www.roche.com, May 2015.

  5. Roche Media Release: FDA grants Roche’s Alecensa (alectinib) accelerated approval for people with a specific type of lung cancer,
    www.roche.com Dec 2015.

  6. Gene Cards. ALK Gene (Protein Coding).
    www.genecards.org.

  7. ALK Inhibitors in Non–Small Cell Lung Cancer: Crizotinib and Beyond.
    M.M. Awad and A.T. Shaw, July 2014.

  8. Alectinib in Crizotinib-Refractory ALK-Rearranged Non–Small-Cell Lung Cancer: A Phase II Global Study.
    S.H.I. Ou, et al, March 2016.

  9. Antitumor activity of the selective ALK inhibitor alectinib in models of intracranial metastases.
    T. Kodama, et al, Nov 2014.

  10. Roche Media Release: Japan becomes first country to approve Roche's alectinib for people with a specific form of advanced lung cancer.
    www.roche.com July 2015.

  11. A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants (ALEX),
    updated Feb 2017, cited on 18/01/2018.

  12. Roche Media Release: Roche receives EU approval of Alecensa (alectinib) for people with previously treated ALK-positive non-small cell lung cancer. roche.com,
    www.roche.com, Feb 2017.

  13. Summary of Product Characteristics [TGA]: Alecensa (alectinib) [PDF],
    Roche Ltd., Jan. 2018.

  14. Summary of Product Characteristics [EMA]: Alecensa (alectinib) [PDF],
    Roche Ltd., Jan. 2018.

  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.
    www.roche.com, May 2017.

  16. Roche Media Release: FDA approves Roche’s Alecensa (alectinib) as first-line treatment for people with specific type of lung cancer.
    www.roche.com, July 2017.  

  17. EMA. Human Medicines: Alecensa (alectinib).
    ema.europe.eu, updated on Nov 2017, cited on 23/01/2018.

Shipping Type Standard
Shipping method Standard (not temperature controlled)
Weight 0.0000
Length (cm) 19
Width (cm) 14
Height (cm) 16
This content has been reviewed by our medical doctor Jan de Witt.

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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.