Cometriq (cabozantinib)

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Cometriq (cabozantinib)

You can order Cometriq (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 Exelixis Inc.
Disease Thyroid Cancer
Indication Progressive, metastatic medullary thyroid cancer (MTC)
Mode of Action Kinase inhibitor (chemotherapy)
Approval Status EMA approved (EU); FDA approved (USA)
CAS Number 849217-68-1
HS Code 29334990
Strength 20 mg, 20 mg & 80 mg

Who is cabozantinib for?

Cometriq (cabozantinib) is indicated for the treatment of patients with progressive, metastatic medullary thyroid cancer (MTC) [1][2].

Recommended dose

Complete information about Cometriq (cabozantinib) dosage and administration can be found here [3][2].
The standard dosage is:
  • 140 mg orally, once daily
  • Patients should not eat for at least 2 hours before and at least 1 hour after taking it [1][2]
  • Cabozantinib tablets should not be substituted with cabozantinib capsules
It can be expected that a majority of patients will require one or more dose adjustments (reduction and/or interruption) due to toxicity. When dose reduction is necessary, it is recommended to reduce to 100 mg daily, taken as one 80 mg capsule and one 20 mg capsule, and then to 60 mg daily, taken as three 20 mg capsules [2][3].
Consult your treating doctor for personalised dosing.

What is cabozantinib and how does it work?

Cometriq (cabozantinib) is a cancer medicine indicated for the treatment of patients with progressive, metastatic medullary thyroid cancer (MTC) [1][2].

The active substance in Cometriq, cabozantinib, is a tyrosine kinase inhibitor. It blocks the activity of enzymes known as tyrosine kinases. These enzymes can be found in certain receptors 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 receptors in cancer cells, the medicine reduces the growth and spread of the cancer [1].

What is cabozantinib's approval status?

Cometriq (cabozantinib) was approved by:
  • FDA (USA) on November 29, 2012 [4]
  • EMA (EU) on March 26, 2014 [1]
for progressive, metastatic medullary thyroid cancer (MTC) [1][2].

The approvals were based on a study involving 330 adults with medullary thyroid cancer that could not be treated with surgery, where the cancer was extensive or had spread to other parts of the body. The main measure of effectiveness was progression-free survival (how long the patients lived before their disease got worse): in patients given Cometriq (cabozantinib) this was 11.2 months, compared with 4.0 months in those given placebo [1][4]. Results also showed that 27 % of patients treated with Cometriq (cabozantinib) had reductions in tumour size lasting an average of 14.7 months (95% CI: 11.1, 19.3), while patients who received a placebo saw no reductions. Treatment with Cometriq (cabozantinib) did not extend patients’ lives [4].

There are some warnings and precautions associated with Cometriq (cabozantinib). Two of these are the occurrence of gastrointestinal perforations and fistulas, and haemorrhage. See the prescribing information for a complete list [3][2].
References
[1] EMA. Human Medicines: Cometriq (cabozantinib), 26/03/2014 (last update: 24/02/2017), cited on 30/01/2017.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002640/human_med_001726.jsp&mid=WC0b01ac058001d124
[2] Summary of Product Characteristics [FDA]: Cometriq (cabozantinib), Exelixis Inc., Nov. 2012.
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203756lbl.pdf
[3] Summary of Product Characteristics [EMA]: Cometriq (cabozantinib), Ipsen Pharma, Mar 2014.
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002640/WC500163703.pdf
[4] FDA News Release: FDA approves Cometriq to treat rare type of thyroid cancer, 29/11/2012.
https://wayback.archive-it.org/7993/20161022200147/http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm330143.htm









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