2 Information about ribociclib

2 Information about ribociclib

Marketing authorisation

Ribociclib (Kisqali, Novartis) is indicated for 'the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with … fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy.

In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinising hormone-releasing hormone agonist'.

Dosage in the marketing authorisation

The recommended dose is 600 mg (3×200 mg), taken orally, once daily for 21 consecutive days, followed by 7 days off treatment (28‑day cycle). Treatment should be continued as long as the patient is having clinical benefit from therapy or until unacceptable toxicity happens.

Management of severe or intolerable adverse drug reactions may need temporary dose interruption, reduction or discontinuation of Kisqali.

Price

£2,950 for a 63‑tablet pack of 200 mg tablets (excluding VAT; British national formulary online, accessed March 2019).

The company has a commercial arrangement. This makes ribociclib 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)