MILAN (ITALPRESS) – Novartis announces the approval of rebocyclability in association with endocrine therapy (ET) with aromatase inhibitors, for the adjuvant treatment of patients with breast cancer in the initial stage, positive for hormonal and negative receptors for receptor 2 of the human epidermal growth factor (HR+/HER2-), with high risk of recurrence The notice of publication of the classification and price determination on the institutional site of the Italian Pharmaco Agency (AIFA) was published in the Official Journal n.54 of 06-03-2026. 13 Breast cancer is the most frequent neoplasia in women in Italy, with almost 54,000 new cases estimated in 2025 14; at the same time, breast cancer HR+/HER2- represents about 70% of all new breast cancer diagnoses. For many patients, the risk of relapse of the disease, despite adjuvant endocrine therapy, remains substantial even at a distance of decades; and when, in most cases, the relapse occurs as a metastatic disease 15-20- Rosanna D’Antona, President of Europa Donna Italia, states: “In early breast cancer, fear of a possible relapse continues to be a concrete concern for many women. Looking to the future with greater confidence, being able to feel protected compared to a possible return of the disease, preserving the quality of life, are fundamental needs of patients. Access to new therapeutic opportunities able to respond to these needs is therefore an important advance, especially when it goes in the direction of an increasingly targeted and attentive care to the person.”.
Medical needs still unsatisfied stress the need for new therapeutic options to offer patients a concrete chance of healing. Giuseppe Curigliano, Professor of Medical Oncology at the University of Milan and Director of the New Pharmaceutical Development Division for Innovative Therapies at the European Institute of Oncology, Elected President of the European Society for Medical Oncology (ESMO) states: “In mammary carcinoma, the prevention of a possible return of the tumor is a crucial aspect to aim for the healing of an increasing number of patients and, at the same time, avoid the clinical, social and economic consequences related to the progression of the disease towards metastatic forms. This is why it is essential to continue investing in research and make innovative therapeutic options available to patients, able to offer more effective protection in the early setting.” The approval of the new therapeutic option is based on the data of Phase III NATALEE, which confirms the effectiveness and favorable profile of drug tolerance. The updated data at 5 years, presented at the ESMO 2025 Congress, shows that the CDK4/6 inhibitor of Novartis reduces the risk of relapse of 28.4% in the vast population of patients enrolled in the study with survival rates free from invasive disease (iDFS) at five years of 85.5% compared to 81.0% with the ET alone, with an absolute clinically significant improvement of 4.5%. The drug also showed a reduction of about 30% of the risk of developing metastases at a distance, which are the main cause of mortality in breast cancer.
Michelino De Laurentiis, Director of the Department of Senological Oncology and Toraco-Polmonare, Istituto Nazionale Tumori IRCCS Fondazione “G. Pascale” in Naples, explains: “The approval of this new therapeutic option in adjuvant marks a fundamental step and represents a concrete hope for many patients in Italy. In fact, despite standard therapies, for a significant number of women the risk of relapse remains high: about one out of five patients goes to a recovery of the disease within 5 years. The results of the NATALEE study clearly highlight the additional benefit obtained with this therapy compared to endocrine therapy alone. Moreover, the drug is distinguished by a favorable tolerability profile, with adverse events mostly asymptomatic that, in most cases, do not compromise the quality of life and adherence to treatment”. In addition to clinical value, the adoption of innovative therapies in the adjuvant setting could also have a positive impact on the sustainability of the National Health Service. According to an analysis recently conducted by Novartis along with the CERGAS Research Centre at Bocconi University, the adoption of this new therapeutic option in the early stages of the disease is an investment for the entire health system. Reducing the risk of relapse, the therapy contributes over time to contain direct costs for the National Health Service, those related to social benefits (INPS) and productivity losses associated with metastatic disease. As part of the analysis, the balance between sustained costs and generated benefits results in a overall favourable economic value. In perspective, this tertiary prevention strategy contributes to progressively reduce the new cases of metastatic disease, with a positive impact on clinical, social and economic load. 12 Roberta Rondena, Country Value & Access Head, Novartis Italia, states: “For over 35 years Novartis has been involved in the breast cancer area. We are proud of the approval of our therapy in Italy, which expands the possibilities of a future free from disease for an increasing number of patients. This important FA-11613281, March 2026 goal, made possible thanks to dialogue and continuous collaboration with regulators, represents a significant progress: reducing the risk of relapse, preserving the quality of life, is an investment that generates value for patients, for the National Health Service and, more generally, for the overall sustainability of the health system.”.
– photos of repertoire IPA Agency –
(ITALPRESS).
