Novartis secures MHRA authorisation for ribociclib

Breast cancer therapy offers hope for patients at risk of recurrence

Novartis UK announced the Medicines and Healthcare products Regulatory Agency (MHRA) has authorised ribociclib for adjuvant treatment in combination with an aromatase inhibitor (AI) for patients with HR+/HER2- early breast cancer at high risk of recurrence.

Previously, this treatment was only licensed for advanced breast cancer. The MHRA decision is based on phase III NATALEE trial results, which showed ribociclib combined with AI reduces the risk of invasive disease, recurrence or death compared to AI alone.

Breast cancer is the most common cancer in the UK and HR+/HER2- is the most frequent subtype. Despite current treatment options, people with HR+/HER2- early breast cancer remain at risk of the cancer returning, often as an incurable advanced disease.

“The possibility of breast cancer returning can be a continuous concern,” said Stephen Johnston, Professor of Breast Cancer Medicine, Consultant Medical Oncologist and Head of the Breast Unit at the Royal Marsden NHS Foundation Trust. “The introduction of ribociclib as a treatment option for early-stage breast cancer is a promising development.”

The phase 3 NATALEE trial demonstrated a 25.1% reduction in invasive disease-free survival events compared to using an AI alone. No new safety signals were reported, with the most common adverse drug reactions being neutropenia, infections, nausea, headache, fatigue, leukopenia and abnormal liver function tests.

Novartis continues to evaluate patients for longer-term outcomes, including overall survival. “This announcement reinforces Novartis’ 30-year legacy in driving scientific advancements for people affected by breast cancer,” said Gerrit Zijlstra, Chief Medical Officer for the UK & Ireland at Novartis.

Following the MHRA authorisation, the National Institute for Health and Care Excellence (NICE) and Scottish Medicines Consortium (SMC) submissions are under review to secure NHS reimbursement.