The Green Light for Ribociclib

NICE’s proposal specifically targets patients in England diagnosed with hormone receptor (HR)-positive, HER2-negative early breast cancer. This particular subtype represents approximately 68% of all breast cancer cases, making it the moast prevalent form of the disease.

The Recurrence Challenge

Breast cancer remains the most frequently diagnosed cancer in the United kingdom, with over 56,000 new cases identified annually, according to Cancer Research UK. While the 10-year overall survival rate stands at 76%, a significant challenge persists: recurrence.

• Approximately 30% of patients experiance a recurrence of breast cancer despite initial treatments.
• The risk of recurrence is elevated in patients exhibiting specific clinical or pathological characteristics, including:
  • Multiple positive lymph nodes
  • Large tumor size
  • High cellular proliferation, as indicated by tumor grade or biomarkers

Ribociclib: An Expanded Role

Ribociclib had already been approved for use in combination with fulvestrant, an oestrogen receptor antagonist, for adults with advanced or metastatic HR-positive, HER2-negative breast cancer who had previously undergone endocrine therapy. Now, its role is expanding.

According to NICE’s draft guidance, ribociclib can be used in early-stage breast cancer following surgery or other primary treatments. The oral medication should be administered alongside a luteinising hormone-releasing hormone (LHRH) agonist in premenopausal or perimenopausal women, as well as in men.

NICE estimates that this expanded use of ribociclib could benefit up to 4,000 individuals.

How Ribociclib Works

Ribociclib functions by targeting cyclin-dependent kinase (CDK) 4 and CDK 6 proteins, which play a crucial role in the growth and division of cancer cells. It is indeed administered in conjunction with an aromatase inhibitor to reduce oestrogen levels in the body.

Side Effects to Consider

Like all medications, ribociclib can cause side effects. Common side effects include:

• Fatigue
• Anemia
• Increased risk of infection
• Rash
• dizziness
• Gastrointestinal symptoms

The Evidence is Still Developing

NICE has stated that clinical trial data suggests that ribociclib, when combined with an aromatase inhibitor, may prolong the progression-free interval compared to using an aromatase inhibitor alone. However, it is vital to note that overall survival benefits remain uncertain as the trial is still in progress.

Direct comparisons between ribociclib plus an aromatase inhibitor and abemaciclib plus endocrine therapy (the current standard treatment) have not been conducted. However, NICE notes that indirect comparisons suggest similar effectiveness.

Targeting High-Risk Cases

The treatment is specifically recommended for patients whose cancer has spread to the axillary lymph nodes. Eligibility criteria include:

• Involvement of four or more lymph nodes, or
• Involvement of one to three lymph nodes with a primary tumor of grade 3 or at least 5 cm in size

The appraisal committee resolute that ribociclib, when used with an aromatase inhibitor, is both clinically effective and cost-effective for this particular subgroup of patients.

Broader Use Not Yet Recommended

NICE has concluded that the available data is currently insufficient to recommend the routine use of ribociclib for all high-risk early breast cancer patients. The organization has requested additional evidence from Novartis and has scheduled a follow-up committee meeting for June.

The use of ribociclib is contingent upon the manufacturer providing the drug under the terms of a confidential agreement.

Treatment Details

The recommended dosage of ribociclib is 400 mg taken once daily for 21 consecutive days, followed by a 7-day break. This cycle is repeated for up to three years or until disease recurrence or unacceptable toxicity occurs.

When 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.

FAQ: Ribociclib for Early Breast Cancer

What is ribociclib?

Ribociclib (Kisqali) is a medication that targets CDK4 and CDK6 proteins to slow cancer cell growth.

Who is ribociclib for?

It is recommended for patients in England with HR-positive, HER2-negative early breast cancer at high risk of recurrence.

How is it taken?

It is indeed taken orally, typically with an aromatase inhibitor and, for some women and men, an LHRH agonist.

What are the common side effects?

Common side effects include fatigue,anemia,infection risk,rash,dizziness,and gastrointestinal symptoms.

Is it a cure for breast cancer?

No, it is an adjuvant treatment to reduce the risk of recurrence after initial treatments like surgery.