2 Information about cabozantinib

2 Information about cabozantinib

Marketing authorisation indication

Cabozantinib (Cabometyx, Ipsen) is indicated for 'the treatment of advanced renal cell carcinoma in untreated adults with intermediate‑ or poor‑risk' as defined in the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) criteria'.

Dosage in the marketing authorisation

Cabozantinib is for oral use. The recommended dose is 60 mg once daily. Treatment should continue until the patient is no longer clinically benefitting from therapy or until unacceptable toxicity occurs.

Management of suspected adverse drug reactions may require temporary treatment interruption and/or dose reduction. When dose reduction is necessary, it is recommended to reduce to 40 mg daily, and then to 20 mg daily.

Price

£5,143 per pack of 30×60 mg tablets (excluding VAT; British National Formulary online, accessed August 2018).

The company has a commercial arrangement. This makes cabozantinib available to the NHS with a discount. The size of the discount is commercial in confidence. It is the company's responsibility to let relevant NHS organisations know details of the discount.

  • National Institute for Health and Care Excellence (NICE)