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Ribociclib with fulvestrant for treating hormone receptor-positive, HER2-negative, advanced breast cancer

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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 x 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 [BNF] online, accessed March 2019).

The company has a commercial arrangement, which would apply if the technology had been recommended.