(Adnkronos) - De Laurentiis (Pascale), approvata dall’Ema questa terapia orale usata per tre anni in combinazione con quella endocrina adiuvante riduce anche del 34% le recidive in pazienti senza metastasi ai linfonodi ascellari. A dimostralo l’aggiornamento dello studio Natalee presentato a Esmo 2024. Coco (Novartis): Obiettivo principale è trovare soluzioni terapeutiche sempre più innovative. Novartis è impegnata in ambio di ricerca clinica con più di 240 studi clinici ogni anno”.
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00:00The Rebociclib oral therapy has obtained the approval of the EMA, the European drug regulatory body,
00:13for the treatment of the early mammary tumor HR positive, R2 negative, in a large population
00:19of patients at a high risk of recidivism. The approval is based on the study of three phases
00:25of which, at ESMO, updated data have been presented, which have shown how Rebociclib,
00:30in combination with endocrine-inducing therapy, offers a clinically significant benefit
00:35in terms of survival free from recidivism. A therapeutic indication that will allow about
00:40twice as many women with early mammary tumor, including those with lymph nodal
00:44involvement-free disease, to benefit from it in Europe, having at their disposal a new
00:50therapeutic option in two, including a day for three years, capable of significantly reducing
00:54the risk of recidivism. Despite endocrine therapy, in fact, more than a third of patients
00:59with an early mammary tumor diagnosis, sensitive hormone, in an advanced stage,
01:03could develop metastasis in other parts of the body. As Professor Michelino de Laurentiis,
01:08Director of the Complex Structure of Clinical Oncology and Experimental Dysenology of the
01:13Instituto Nazionale dei Tumori Giovanni Pasquale di Napoli, the four-year analysis of the study
01:18has shown a further improvement of the benefit, always in terms of survival free from metastasis,
01:24even after the completion of the three-year treatment period. The four-year study has shown
01:30that this therapy with Rebociclib, performed with the assumption of two compresses per day
01:35for three years, in addition to standard hormone therapy, further reduces the risk,
01:40compared to all other treatments, by about 29%. This reduction even appears more
01:47marked in some populations of patients who previously could not benefit from these
01:52additional therapies, such as those without metastasis of the axillary lymph nodes, where
01:57even the reduction reaches 34%. So it is a further step forward towards
02:05what is our final goal, which we will soon add, which is a 0% risk of recidivism
02:11which will obviously equate to 100% healing. For years we have believed that the
02:16hormonal-sensitive tumor was a tumor with good prognosis. In reality it is, it is not particularly aggressive,
02:22but what is the problem? That recidivisms are distributed over a very, very long time frame.
02:29Today we know that they can happen even at a distance of 20 or 30 years and they colonize
02:36different organs from the one at the beginning, which is the breast, and they are virtually incurable,
02:41except in a minority of cases. So it is important to reduce recidivism to increase
02:46the definitive healing rates. A 30-year commitment in clinical research on breast cancer
02:51explains Paola Poco, Laferced doctor of Novartis Italy, a pharmaceutical industry
02:56producer of Ribociclib, which has allowed to improve the quality of life of thousands of women
03:02with breast tumors, a pathology that affects only in Italy 800,000 people per 55,000 new diagnoses per year.
03:09The main goal is to try to find increasingly innovative therapeutic solutions.
03:15Novartis is committed in clinical research with more than 240 clinical studies every year.
03:24Of course, this alone is not enough, an active collaboration with all stakeholders of the health system is necessary
03:33in order to investigate more and more the unmet needs of patients, in order to go more and more
03:43towards a personalization of the treatment and towards the possibility of ensuring that these treatments
03:51can then actually reach the patient's bed, also through partnerships with associations,
03:59with institutions that allow more and more equitable access to the cures.