Zykadia (ceritinib)

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Zykadia (ceritinib)

Zykadia (ceritinib) is a medication used for the treatment of ALK-positive metastatic non-small cell lung cancer (NSCLC).

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

Oncology Lung Cancer
Marketing Authorisation Holder Novartis Europharm Limited
Mode of Action Kinase inhibitor (chemotherapy)
Administration Oral
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA, Therapeutic Goods Administration (TGA), Australia
Strength 150 milligram
Package 3x50 Capsules

What is Zykadia (ceritinib) for?

Zykadia (ceritinib) is a kinase inhibitor indicated for the treatment of patients with metastatic ALK-positive NSCLC1,2,3. While the FDA and EMA recommend it for first-line treatment1,2, the TGA recommend it for patients whose disease has progressed, or who are intolerant of crizotinib3.

How does Zykadia (ceritinib) work?

Mutations of the ALK gene can occur in several different types of cells, including lung cells, and can result in the development of a tumour4. ALK gene mutations occur in 2 to 7% of patients with NSCLC5. Ceritinib is an ALK-inhibitor, which acts by inhibiting the activity of the ALK protein, and may therefore prevent ALK-positive NSCLC-cells from growing and spreading6.

Is Zykadia (ceritinib) approved?

Zykadia (ceritinib) was approved as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive locally advanced or metastatic non-small cell lung cancer (NSCLC) by:

  • Food and Drug Administration (FDA), USA:

    • April 4, 20145 with an accelerated approval for ALK-positive NSCLC in patients whose disease has progressed, or who are intolerant of crizotinib

    • May 26, 20177 with regular approval for previously untreated ALK-positive metastatic NSCLC (first-line treatment)

  • European Medical Agency (EMA), European Union, May 6, 20156 – first-line treatment

  • Therapeutic Goods Administration (TGA), Australia, March 3, 20163– second-line after crizotinib.

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

How is Zykadia (ceritinib) taken?

The standard dosage is1,2,3:

  • 750 mg  (5 capsules) orally once daily.

Taken at least 1 hour before or at least 2 hours after a meal.

Complete information about Zykadia (ceritinib) dosage and administration can be found in the official prescribing information listed in our resources section1,2,3.

Note: Please consult with your treating doctor for personalised dosing.

Are there any known adverse reactions of Zykadia (ceritinib)?

Common adverse reactions

The most common side effects are6:

  • diarrhoea
  • nausea (feeling sick)
  • vomiting
  • tiredness
  • abnormal liver tests, abdominal (belly) pain
  • decreased appetite
  • weight loss
  • constipation
  • rash
  • increases in the level of a waste product called creatinine in the blood (a possible sign of kidney problems)
  • oesophageal disorder and anaemia (low levels of red blood cells)6

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.

More Information
Working ingredient ceritinib
Shipping method Standard (not temperature controlled)
Package 3x50
Therapeutic Area Oncology
Oncology Lung Cancer
Indication Anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC)
Administration Oral
Mode of Action Kinase inhibitor (chemotherapy)
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA, Therapeutic Goods Administration (TGA), Australia
Marketing Authorisation Holder Novartis Europharm Limited
HS Code N/A
CAS Number 1032900-25-6

Second-line treatment approval

The European Medical Agency (EMA) and the Therapeutic Goods Administration (TGA) approvals of Zykadia (ceritinib) for ALK-positive NSCLC in previously treated patients were based on two main global, multicentre, open-label, single-arm studies (study X2101 and study A2201) which involved in total 303 patients in whom the disease progressed despite previous treatment with crizotinib (Xalkori). In both studies, the medicine was not compared with any other treatment2,3.

Results

Among the efficacy outcome measures were overall response rate (ORR), the median duration of response (DoR), and median progression-free survival (PFS).

The ORR was:

  • 56.4%
    [95% CI: 48.5, 64.2] in Study X2101

  • 37.1%
    [95% CI: 29.1, 45.7] in study A2201

The DoR was:

  • 8.3 months
    [95 % CI: 6.8, 9.7]  in Study X2101

  • 9.2 months
    [95 % CI: 5.6, NE] in study A2201

The PFS was:

  • 6.9 months
    [95 % CI: 5.6, 8.7] in Study X2101

  • 5.7 months
    [95 % CI: 5.3, 7.4] in study A2201

First-line treatment approval

The Food and Drug Administration (FDA), USA, European Medical Agency (EMA), European Union, approval of ceritinib for ALK-positive NSCLC in previously untreated patients was based on an open-label, randomized, active-controlled multicenter Study (ASCEND-4) involving 376 previously untreated ALK-positive NSCLC patients who were treated with Zykadia (ceritinib) or chemotherapy1,2.

Results

Among the efficacy outcome measures were overall response rate (ORR), the median duration of response (DoR), and median progression-free survival (PFS). In patients with measurable central nervous system (CNS) lesions on baseline brain scans, the confirmed overall intracranial response rate (OIRR) and median CNS response duration were measured.

The median PFS was:

  • 16.6 months [95 % CI: 12.6, 27.2] in the ceritinib arm

  • 8.1 months [95 % CI: 5.8, 11.1] in the chemotherapy arm

The ORR was:

  • 73% [95% CI: 66, 79] in the ceritinib arm

  • 27% [95% CI: 21, 34] in the chemotherapy arm

The median DoR was:

  • 23.9 months [95% CI: 16.6, not estimable] in the ceritinib arm

  • 11.1 months [95% CI: 7.8, 16.4] in the chemotherapy arm

The OIRR was:

  • 57% [95% CI: 37, 76] in the ceritinib arm

  • 22% [95 % CI 9, 42] in the chemotherapy arm

The median CNS response duration was:

  • 16.6 months [95 % CI: 8.1, NE, not estimable] in the ceritinib arm

  • not estimable [95 % CI: 1.5, NE] in the chemotherapy arm

Shipping Type Standard
Shipping method Standard (not temperature controlled)
Dynamic Weight No
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Patient reviews

 Tomasz Maćkowiak

During the transaction process I was very well informed by the TheSocialMedwork team. They have put as much of their effort to offer best service to me. Moreover the medicine I have ordered was imported two weeks earlier then it was expected. I highly recommend The Social Med Work.

Patient reviews

 Emina Mušović

Thank you for the wonderful cooperation! It's very reserved of us to say we're pleased because you really resolved all our doubts. The medicine has now arrived and we hope it helps. We know we were difficult, with the million different questions but well... That's all behind us now. Strongly recommended! :)

Patient reviews

 Mohamed Rahmat

I am fully satisfied with your online support service. Happy to deal with you.. fast & very fast support.. did not have to wait even 5 minutes! THANK YOU MEDWORK

Questions our patients are asking

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By using TheSocialMedwork you will receive genuine medicines in perfect condition, no matter where you live.
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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.