EC authorises ribociclib for advanced breast cancer

The breast cancer therapy ribociclib (Kisqali) has now been authorised by European Commission for the treatment of advanced breast cancer. It has been licensed for use in the EU as a first-line treatment for postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally advanced or metastatic breast cancer, in combination with an aromatase inhibitor.

Ribociclib is a selective cyclin-dependent kinase 4 and 6 inhibitor, which works by slowing the growth and division of tumour cells. Unlike many other types of therapy for advanced breast cancer, it is an oral treatment and therefore can be taken by the patient at home. It is taken with or without food at a dose of 600mg once daily (three 300mg tablets) for three weeks, followed by one week off treatment. It can be used in combination with any one of the aromatase inhibitors (letrozole, anastrozole or exemestane), which should be taken continuously once daily throughout the four-week cycle.

The most common adverse reactions include neutropenia, nausea, fatigue, diarrhoea, leukopenia, alopecia, vomiting, constipation, headache and back pain. It can also prolong the QT interval and increase serum transaminase levels, and these effects should be monitored for throughout treatment. Dose reduction (or discontinuation) may be necessary depending on tolerability.

The EU licence follows a positive opinion from the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP). The committee’s decision was based on data from the phase 3 MONALEESA-2 trial, which enrolled 668 postmenopausal women with HR+/HER2- locally advanced or metastatic breast cancer who had received no prior systemic therapy. The trial showed that ribociclib plus the aromatase inhibitor letrozole significantly increased progression-free survival compared with placebo plus letrozole (median 25.3 months (95% CI 23.0–30.3) with ribociclib/letrozole versus 16.0 months (95% CI 13.4–18.2) with placebo/letrozole; hazard ratio 0.568, p<0.0001). In addition, ribociclib/letrozole reduced tumour size by at least 30% in 55% of patients with measurable disease.

NICE is currently developing technology appraisal guidance on ribociclib, but a date has not been set yet for publication.

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