, 2025-04-25 13:25:00
The National Institute for Health and Care Excellence (NICE) has recommended ribociclib (Kisqali, Novartis) as an adjuvant treatment for early breast cancer in patients at high risk of recurrence.
The recommendation applies to patients in England with HR-positive, HER2-negative early breast cancer. This is the most common breast cancer subtype, accounting for around 68% of all cases.
One in Three Patients Relapse After Initial Treatment
Breast cancer is the most commonly diagnosed cancer in the UK, with more than 56,000 new cases each year, according to Cancer Research UK. The 10-year overall survival rate is 76%.
Despite initial treatment, around 30% of patients experience recurrence. The risk is higher for those with certain clinical or pathological features, including multiple positive lymph nodes, large tumour size, or high cellular proliferation measured by tumour grade or biomarkers.
Expanded Indication for Ribociclib
Ribociclib is already approved in combination with the oestrogen receptor antagonist fulvestrant for advanced or metastatic HR-positive, HER2-negative breast cancer in adults who have had previous endocrine therapy.
Under NICE’s new draft guidance, ribociclib can now be used in early-stage breast cancer following surgery or other primary treatments. The drug, which is taken orally, should be combined with a luteinising hormone-releasing hormone agonist in premenopausal or perimenopausal women and in men.
NICE estimates that up to 4000 people could benefit from this expanded use.
Mechanism of Action and Side Effects
Ribociclib targets CDK 4 and CDK 6 proteins, which are involved in cancer cell growth and division. It is taken with an aromatase inhibitor to reduce oestrogen levels.
Common side effects include fatigue, anaemia, infection risk, rash, dizziness, and gastrointestinal symptoms.
Clinical Trial Evidence Still Evolving
NICE said that clinical trial data suggest that ribociclib plus an aromatase inhibitor may extend the progression-free interval compared with using an aromatase inhibitor alone. However, overall survival benefits remain unclear as the trial is ongoing.
Ribociclib plus an aromatase inhibitor has not been directly compared in trials with abemaciclib plus endocrine therapy, the usual treatment. However, indirect comparisons suggest similar effectiveness, according to NICE.
Targeted Use for High-Risk Patients
The treatment is recommended for patients whose cancer has spread to axillary lymph nodes. Eligibility includes involvement of four or more nodes, or one to three nodes with a primary tumour of grade 3 or at least 5 cm in size.
The appraisal committee found ribociclib with an aromatase inhibitor to be clinically and cost effective for this subgroup.
Use in Wider Population Not Yet Recommended
NICE concluded that data were too uncertain to recommend routine use for all high-risk early breast cancer patients. It has requested additional evidence from Novartis. A follow-up committee meeting is scheduled for June.
Use of the drug is conditional on the manufacturer supplying the drug under the terms of a confidential agreement.
Treatment Regimen and Cost
Ribociclib should be taken at a dose of 400 mg once daily for 21 consecutive days, followed by 7 days off, for up to 3 years or until disease recurrence or unacceptable toxicity.
If taken with an aromatase inhibitor, ribociclib should be used continuously throughout the 28-day cycle.
The list price for a 21-pack of 200 mg tablets is £983.33, excluding VAT.
Ribociclib will be made available through interim funding from the Cancer Drugs Fund and must be funded in England within 90 days of final guidance publication.
Dr Sheena Meredith is an established medical writer, editor, and consultant in healthcare communications, with extensive experience writing for medical professionals and the general public. She is qualified in medicine and in law and medical ethics.
