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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