Zykadia (ceritinib)

pill
100 % legal and regulated
Secured logistics globally
24/7 track & trace delivery
Safe payment by bank transfer or credit card

We are registered as an independent intermediary for medicines with the Dutch Ministry of Health

Zykadia (ceritinib)

How to buy Zykadia: You can order Zykadia (ceritinib) 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 Novartis
Disease Lung Cancer
Indication ALK-positive NSCLC
Mode of Action Kinase inhibitor (targeted therapy)
Approval Status EMA approved (EU); FDA approved (USA); TGA approved (AUS)
CAS Number 1032900-25-6
Strength 150 mg

Who is ceritinib for?

Zykadia (ceritinib) is indicated for the treatment of ALK-positive metastatic non-small cell lung cancer (NSCLC) [1][2][3]. While the FDA and EMA recommend it for first-line treatment [1][2], the TGA recommend it for patients whose disease has progressed on, or who are intolerant of crizotinib [3].

Recommended dose

Complete information about Zykadia (ceritinib) dosage and administration can be found here: [1][2][3].
The standard dosage is:
  • 750 mg  (5 capsules) orally once daily.
  • Taken at least 1 hour before or at least 2 hours after a meal.
Consult your treating doctor for personalised dosing.

What is ceritinib and how does it work?

Zykadia (ceritinib) is a kinase inhibitor indicated for the treatment of patients with metastatic ALK-positive NSCLC [1][2][3].
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 [4]. ALK gene mutations occur in 2 to 7 % of patients with NSCLC [5]. Ceritinib 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 [6].

What is ceritinib's approval status?

Zykadia (ceritinib) was approved by:
  • FDA (USA) on April 4, 2014 [5]  with an accelerated approval for ALK-positive NSCLC in patients whose disease has progressed on or who are intolerant of crizotinib; and on May 26, 2017 [7] with regular approval for previously untreated ALK-positive metastatic NSCLC
  • EMA (EU) on May 6, 2015 [6]
  • TGA (AUS) on March 3, 2016 [3]
as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive locally advanced or metastatic non-small cell lung cancer (NSCLC).
The EMA and TGA approvals of 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 treatment. The overall response rate (ORR) was 56.4 % [95 % CI: 48.5, 64.2] in Study X2101 and 37.1 % [95 % CI: 29.1, 45.7] in study A2201. The median duration of response (DoR) was 8.3 months [95 % CI: 6.8, 9.7]  in Study X2101 and 9.2 months [95 % CI: 5.6, NE] in study A2201. The median progression-free survival (PFS) was 6.9 months [95 % CI: 5.6, 8.7] in Study X2101 and 5.7 months [95 % CI: 5.3, 7.4] in study A2201 [2][3].
The FDA and EMA 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 chemotherapy. The median PFS was 16.6 months [95 % CI: 12.6, 27.2] in the ceritinib arm and 8.1 months [95 % CI: 5.8, 11.1] in the chemotherapy arm. The ORR, was 73 % [95 % CI: 66, 79] and 27 % (95 % CI: 21, 34) in the ceritinib and chemotherapy arms, respectively. The median DoR was 23.9 months [95 % CI: 16.6, not estimable] and 11.1 months [95 % CI: 7.8, 16.4] in the ceritinib and chemotherapy arms, respectively. In patients with measurable central nervous system (CNS) lesions on baseline brain scans, the confirmed overall intracranial response rate (OIRR) was 57 % [95 % CI: 37, 76] in the ceritinib arm and 22 % [95 % CI 9, 42] in the chemotherapy arm. The median CNS response duration was 16.6 months [95 % CI: 8.1, NE] and not estimable [95 % CI: 1.5, NE] in the ceritinib and chemotherapy arms, respectively [1][2][7].
The most common side effects are 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].
References
[1] Summary of Product Characteristics [FDA]: Zykadia (ceritinib), Novartis, May 2017.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205755s009lbl.pdf
[2] Summary of Product Characteristics [EMA]: Zykadia (ceritinib), Novartis, Mar. 2017.
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003819/WC500187504.pdf
[3] Summary of Product Characteristics [TGA]: Zykadia (ceritinib), Novartis, Mar. 2016.
https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2016-PI-01610-1
[4] FDA News Release: FDA approves new oral therapy to treat ALK-positive lung cancer, 11/12/2015.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm476926.htm
[5] Drugs.com. FDA approves Zykadia, Apr. 2014.
https://www.drugs.com/newdrugs/fda-approves-zykadia-ceritinib-metastatic-non-small-cell-lung-cancer-4035.html
[6] EMA. Human Medicines: Zykadia (ceritinib), 04/06/2015, (last update: 23/03/2017), cited on 20/06/2017.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003819/human_med_001860.jsp&mid=WC0b01ac058001d124
[7] FDA. Approved Drugs: FDA broadens ceritinib indication to previously untreated ALK-positive metastatic NSCLC, 26/05/2017.
https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm560873.htm

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.

How can we help?

★ ★ ★ ★ ★
 
 

We've received requests for support from patients and doctors in over 120 countries, and delivered medicines to 6 continents. They've given us a 5 star rating for our service. Read what our friends from around the world are saying...

"My experience has been excellent. TheSocialMedwork were totally knowledgeable about the medicine I was looking for, and how to get it delivered to me quickly and easily. I UNCONDITIONALLY recommend TSM to anyone, it is truly a world-class organisation."

— Charles, USA

"During the transaction process I was very well informed by TheSocialMedwork team. They have put so much effort to ensure the best service was offered to me. Moreover the medicine I ordered was imported two weeks earlier. I highly recommend TheSocialMedwork."

— Tomasz, Poland

"I hope you know how needed you are and what it means to get a prompt, succinct and helpful reply. You are our hero. You have given us realistic hope in obtaining needed drugs in a timely way."

— Regina, US

"TheSocialMedwork were so helpful in getting the right medication to me, expediting its delivery, and keeping in touch. They simply can't do enough to help you. I would not hesitate to recommend TheSocialMedwork to anybody. Lovely people."

— Stephen, UK

"Totally awesome! Keep up the great work you're doing!"

— Dee, Australia

"When the doctor tells you that there are no treatments left to try, search further - there may be new treatments in other countries."

— Charlotte, The Netherlands

"TheSocialMedwork's professional capabilities, kindness and patience deserve our gratitude and respect."

— Haoyu, China

"My daughter died at the age of 21 because she couldn't get the treatment that might have saved her life. Now TheSocialMedwork might be able to help people like Abigail to get the best treatment."

— Frank, Virginia, USA

"The team is highly professional, friendly and will take care of everything. More options for doctor and patients. This service is transparent, unique and necessary. Keep it up!"

— Pa Tric, Germany

"Excellent communication and clarifications given every time when requested. They also provide fantastic support and updates from the start till the end of the process of the medicine provisioning."

— Milos, Serbia & Montenegro

Registered with the Dutch Ministry of Health as an independent intermediary, Registration number 6730 BEM
Registered as a USA Delaware LLC.



Our service uses cookies.