Cabometyx (cabozantinib)

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Cabometyx (cabozantinib)

How to buy Cabometyx: You can order Cabometyx (cabozantinib) 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 Ipsen Pharma
Disease Kidney Cancer
Indication Renal cell carcinoma
Mode of Action Tyrosine kinase inhibitor
Approval Status EMA approved (EU); FDA approved (USA)
CAS Number 849217-68-1
Strength 20 mg, 40 mg, 60 mg

Who is cabozantinib for?

Cabometyx (cabozantinib) is indicated for the treatment of patients with advanced renal cell carcinoma (a type of kidney cancer) who have received prior anti-angiogenic therapy [1][2] (therapy that inhibits the formation of new blood vessels that supply the tumour with oxygen and nutrients [5]). In December 2017 the FDA extended the approval to previously untreated patients with advanced renal cell carcinoma (RCC) [6].

Recommended dose

Complete information about Cabometyx (cabozantinib) dosage and administration can be found here [1][2].
The standard dosage is:
  • 60 mg orally, once daily
  • Patients should not eat for at least 2 hours before and at least 1 hour after assumption
  • Cabozantinib tablets should not be substituted with cabozantinib capsules.  
Consult your treating doctor for personalised dosing.

What is cabozantinib and how does it work?

Cabometyx (cabozantinib) is a cancer medicine used to treat adults with advanced renal cell carcinoma (a type of kidney cancer) who have received prior anti-angiogenic therapy [1][2]. The active substance in Cabometyx, cabozantinib, is a ‘tyrosine kinase inhibitor’. This means that it blocks the activity of enzymes known as tyrosine kinases. These enzymes can be found in cancer cells, where they activate several processes including cell division and the growth of new blood vessels to supply the cancer. By blocking the activity of these enzymes in cancer cells, Cabometyx (cabozantinib) reduces the growth and spread of the cancer [3].

What is cabozantinib's approval status?


Cabometyx (cabozantinib) was approved by:
  • FDA (USA) 
    • on April 25, 2016 [4] as second line treatment
    • on December 19, 2017 [6] as first line treatment
  • EMA (EU) on  September 9, 2016 [3]
for advanced renal cell carcinoma previously treated with an anti-angiogenic therapy.The approvals were based on a study involving 658 adults with advanced renal cell carcinoma that had got worse despite treatment with an anti-angiogenic therapy. In the study, Cabometyx (cabozantinib) was compared with the cancer medicine everolimus [1][2]. Results showed a progression-free survival (time patients lived without their disease getting worse) of 7.4 months on average (95 % CI: 6.6, 9.1) compared with 3.8 months  (95 % CI: 3.7, 5.1) in patients treated with everolimus [1]. The overall response rate (ORR) was 24 % (95 % CI: 19, 29) with cabozantinib and 4 % (95 % CI: 2, 7) [1]. Preliminary results indicated that patients treated with Cabometyx (cabozantinib) lived overall longer than patients treated with everolimus (an average of 21.4 months compared with 16.5 months) [3].
References
[1] Summary of Product Characteristics [EMA]: Cabometyx (cabozantinib), Ipsen Pharma, Oct. 2016.
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004163/WC500214071.pdf
[2] Summary of Product Characteristics [FDA]: Cabometyx (cabozantinib), Exelixis Inc., Apr. 2016.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208692s002lbl.pdf
[3] EMA. Human Medicines: Cabometyx (cabozantinib), 12/10/2016 (last update: 12/10/2016), cited on 19/01/2017.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004163/human_med_002018.jsp&mid=WC0b01ac058001d124
[4] Drugs.com. Cabometyx (cabozantinib), 05/07/2016, (last update: 01/06/2017), cited on 19/01/2017.
https://www.drugs.com/mtm/cabometyx.html
[5] Cancer.gov. Angiogenesis inhibitors. (last update 7/10/2011), cited on 24/10/2017.
https://www.cancer.gov/about-cancer/treatment/types/immunotherapy/angiogenesis-inhibitors-fact-sheet
[6] FDA Press Release: FDA grants regular approval to Cabometyx for first-line treatment of advanced renal cell carcinoma, 19/12/2017.
https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm589842.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.

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