Around 5,700 people with early breast cancer in England are set to benefit from expanded access to ribociclib, following new guidance from the National Institute for Health and Care Excellence.
The treatment, taken in combination with an aromatase inhibitor, is now approved for hormone receptor-positive, HER2-negative early breast cancer patients at high risk of recurrence, including those whose cancer has not spread to nearby lymph nodes, significantly broadening eligibility.
Ribociclib is a CDK4/6 inhibitor that blocks proteins involved in cancer cell growth. When combined with an aromatase inhibitor, which lowers oestrogen levels, the therapy helps delay or prevent cancer recurrence following initial treatments such as surgery.
Clinical trial data from the NATALEE study showed that the combination significantly improved invasive disease-free survival compared to aromatase inhibitor alone, although overall survival data remains immature.
Director of Medicines Evaluation at NICE, Helen Knight, said:
“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.”
This marks the 25th breast cancer treatment NICE has recommended for NHS use in the past seven years. The expanded access is made possible through a confidential discount agreement with manufacturer Novartis, ensuring cost-effectiveness for the NHS.
NICE already recommends ribociclib for locally advanced or metastatic breast cancer, demonstrating its versatility across different stages of the disease.
The decision addresses a significant unmet need for patients at high risk of recurrence who previously had limited options, especially those ineligible for alternative treatments like abemaciclib. The oral nature of ribociclib also offers greater convenience, potentially improving adherence.
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