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Adverse event reporting information is available at the bottom of this webpage.

This website has been commissioned by Ipsen Pharmaceuticals Ltd. and is intended for an Irish audience

Cabometyx® (Cabozantinib) therapeutic indications

Cabometyx® is indicated as monotherapy treatment of advanced renal cell carcinoma (RCC):

  • in first-line treatment of adult patients with intermediate or poor risk per IMDC criteria.
  • in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy.

Cabometyx® in combination with nivolumab for the first-line treatment of RCC in adults.

Efficacy Information

Efficacy Information

Cabometyx® is the only TKI to show longer overall survival, superior PFS and ORR vs everolimus.*1,2

Footnotes

*Data from METEOR, a Phase 3, randomised, open-label study comparing Cabometyx® monotherapy (n=330) with everolimus (n=328) in adult patients with aRCC progressing after prior anti-VEGF therapy. PFS was the primary endpoint (assessed by IRC in the first 375 patients who underwent randomisation) and ORR and overall survival were secondary endpoints of the study.1,2 Median overall survival data cut-off: October 2016. Median follow-up: 28 months. 430 deaths were recorded (198 for Cabometyx® and 232 for everolimus).2 Median PFS and ORR data cut-off: May 2015. Median follow-up: 11.4 months for Cabometyx®, 11.5 months for everolimus.1

**All 658 randomly assigned patients were included in the analysis.
aRCC, advanced renal cell carcinoma; CI, confidence interval; HR, hazard ratio; IRC, independent review committee; OS, overall survival; PFS, progression-free survival; ORR, objective response rate; TKI, tyrosine kinase inhibitor; VEGF, vascular endothelial growth factor.

References

  1. Choueiri TK, et al. Lancet Oncol. 2016;17(7):917–927.
  2. Motzer RJ, et al. Br J Cancer. 2018;118(9):1176–1178.

For further information, please refer to the Prescribing Information or the Summary of Product Characteristics.

Resources

Adverse events should be reported.
Reporting forms and information can be found at www.hpra.ie or e-mail medsafety@hpra.ie.
The HPRA can also be contacted on +353 16764971. Adverse events should also be reported to Ipsen via email at pharmacovigilance.uk-ie@ipsen.com or phone on +353 1 8098256.

To access relevant information about Renal Cell Carcinoma, please choose one of the following options:

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Adverse events should be reported.
Reporting forms and information can be found at www.hpra.ie or e-mail medsafety@hpra.ie.
The HPRA can also be contacted on +353 16764971. Adverse events should also be reported to Ipsen via email at pharmacovigilance.uk-ie@ipsen.com or phone on +353 1 8098256.

I am a patient

This section provides information to support patients that have been prescribed Cabometyx® (cabozantinib) in Ireland. It is designed for patients in Ireland and should not replace the opinion provided by your healthcare professional or the details contained in the Patient Information Leaflet.

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Reporting of side effects:
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly to the HPRA. Reporting forms and information can be found at www.hpra.ie or email medsafety@hpra.ie. Adverse events should also be reported to Ipsen via email at pharmacovigilance.uk-ie@ipsen.com or phone on +353 1 8098256. By reporting side effects, you can help provide more information on the safety of this medicine.