Ribociclib gets the green light from NICE for HR+, HER2-negative early breast cancer
Ribociclib with an aromatase inhibitor has been approved by NICE for the adjuvant treatment of HR+, HER2-negative early breast cancer.
NICE has recommended Kisqali® (ribociclib) in combination with an aromatase inhibitor as an additional treatment option for HR+, HER2-negative early breast cancer. Specifically for tumors that have responded to initial treatments but there is a high risk of recurrence. The approval means that approximately 5,700 people in the UK with early breast cancer could benefit from a new treatment combination.
In April 2025, NICE approved this treatment combination for early breast cancer patients whose cancer has spread to nearby lymph nodes (lymph node-positive) through interim funding from the Cancer Drugs Fund. In February 2025, the MHRA approved the same combination based on results from the NATALEE Phase III trial, which demonstrated that the addition of ribociclib to aromatase inhibitor reduced the risk of invasive disease-free survival events by 25.1% compared to aromatase inhibitor alone. The most NICE approval means it will also be available for people whose disease hasn’t spread to nearby lymph nodes (lymph node-negative) on the NHS.
Breast cancer drug approvals: the latest news
Read about the approval journey of ribociclib in our breast cancer drug approval roundup article.
Helen Knight, director of medicines evaluation at NICE, commented: “With today’s decision ribociclib becomes the 25th out of 26 breast cancer treatments NICE has recommended for use in the NHS in the last 7 years. This is fantastic news for the tens of thousands of patients and their loved ones who are now benefiting from access to cutting edge new treatments. It is also due in no small part to the willingness of companies to engage with us constructively, as in the case with ribociclib, to ensure the benefits of their treatments are properly presented and appropriately priced.”
Novartis has agreed to a confidential discount to the NHS on the standard price of ribociclib, making it a cost-effective treatment option.
NICE already endorses ribociclib plus fulvestrant as an option for treating HR+, HER2-negative, locally advanced or metastatic breast cancer in adults who have had previous endocrine therapy.