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Cabozantinib Ipsen therapeutic indications

Cabozantinib Ipsen® is indicated as monotherapy for advanced renal cell carcinoma:

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

Cabozantinib Ipsen, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults.

SUMMARY
Cabozantinib Ipsen, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults1.
The CheckMate 9ER trial is a phase 3, randomised, open-label trial assessing Cabozantinib + nivolumab vs. sunitinib in patients with previously untreated advanced renal cell carcinoma (aRCC).
Early tumour control with sustained long-term overall survival demonstrated by Cabozantinib + nivolumab vs sunitinib, in the 68-month CheckMate 9ER follow-up, in patients with previously untreated advanced renal cell
carcinoma (aRCC).2,3
In the intention-to-treat population with previously untreated advanced renal cell carcinoma, at a median follow-up of 67.6 months (60.2 months minimum), CheckMate 9ER data for Cabozantinib + nivolumab demonstrated:3
Almost double the median progression-free survival vs sunitinib3
Sustained long-term overall survival at 67.6 months versus sunitinib3
Established patient safety and tolerability profile2,3

An established safety profile with no new safety signals compared with the previous cut-off was seen in the 67.6-month follow-up.2,3
Discontinuation rates due to TRAEs with Cabozantinib + nivolumab were 6% simultaneously and 1% sequentially, 11% for Cabozantinib alone, 10% for nivolumab alone and 11% with sunitinib.3

One tablet, once a day with adjustable dosing1

Cabozantinib is taken as one tablet, once daily with a recommended starting dose of 40 mg when administered in combination with nivolumab.1 Management of suspected adverse drug reactions may require temporary treatment interruption and/or dose reduction.1

Dosing can be reduced to 20 mg once daily, then 20 mg every other day to manage TRAEs, if required.1

To access relevant information about Renal Cell Carcinoma, please confirm the following:

Adverse events should be reported.
Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in Google Play or Apple App Store. Adverse events should also be reported to Ipsen via email at pharmacovigilance.uk-ie@ipsen.com or phone on 
01753 627777.

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 via the Yellow Card Scheme at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in Google Play or Apple App Store. Side effects should also be reported to Ipsen via email at pharmacovigilance.uk-ie@ipsen.com or phone on 01753 627777. By reporting side effects, you can help provide more information on the safety of this medicine.