ok Aifa a terapia agnostica made in Italy

Green light from the Italian drug agency Aifa to entrectinib, intelligent therapy that has its roots in made in Italy research. The tricolor regulatory body has approved the marketing and reimbursement of Roche’s ‘agnostic’ drug – which acts on the genetic alteration, regardless of the organ affected by the tumor – for the treatment of adult patients with non-small lung cancer Ros1-positive advanced stage (Nsclc) cells not previously treated with Ros1 inhibitors, and for the treatment of adult and pediatric patients 12 years of age and older with solid tumors expressing a fusion of neurotrophic receptor tyrosine kinase genes (Ntrk).

The green light brings with it a change of diagnostic and therapeutic paradigm that moves in the field of precision oncology. It is not the tumor site that guides the therapies, but the mutation, the genetic alteration ‘driver’ that guides the growth of the tumor, regardless of its anatomical location and histological subtype. And Aifa is among the first regulatory bodies in Europe to have identified the tools necessary to govern access to the drug. Central to the new organizational model are the multidisciplinary groups in which the skills of several experts are integrated, including oncologist, pathologist, surgeon, radiologist, radiotherapist, hospital pharmacist and bioinformatician. Among the tasks the interpretation of the genomic profile of a tumor for the recommendation of the most appropriate therapy for the patient, based on the specific alterations detected with latest generation tests for a wide genomic profiling, such as Ngs (Next Generation Sequencing) technology. .

“We are doubly proud of this milestone, achieved thanks to scientific research made in Italy and a cutting-edge regulatory process which, compared to other countries, has made it possible for Italian patients to access an intelligent personalized therapy such as entrectinib – he says. Maurizio de Cicco, president and CEO of Roche Italia – A result that is the umpteenth proof of a fruitful collaboration with the current Aifa leaders that has been consolidating in this pandemic period: from the largest global experimentation in time of Covid with our tocilizumab, to its recognition in 648 for serious patients ; from the approval for emergency use of monoclonal antibodies, to this revolutionary agnostic therapy and target for cancer patients “.

“We are sure – continues de Cicco – to be able to give continuity to this path, given the recent decision to renew the mandate of the two technical commissions and the management of the agency, always setting ourselves as a common goal a wide and fast access to diagnostic innovation and therapeutic with a focus on clinical benefits and the sustainability of the health system “.

The approval of entrectinib as antitumor therapy with agnostic indication “confirms the innovativeness of this therapeutic option for the effective treatment of patients with solid tumors characterized by alterations of the Ntrk or Ros1 genes – comments Filippo de Braud, professor of Oncology at the university degli Studi di Milano and director of the Department of Medical Oncology and Hematology Irccs Foundation National Cancer Institute (Int) of Milan – The value of this target therapy is amply demonstrated by the evidence gathered in clinical trials: high response rates, extended response duration and good tolerability profile. Moreover, thanks to the fact that the drug penetrates the blood brain barrier, good intracranial response rates are obtained, higher than 50% in the presence of brain metastases at baseline “.

The creation of the entrectinib molecule started from the studies conducted in the laboratories of Nerviano medical sciences (Nms), near Milan, and continued through the subsequent phases of clinical development in the Milanese centers of Niguarda Cancer Center and Int. “The fact that entrectinib is designated as an agnostic anti-cancer therapy (i.e. regardless of tumor type), which is now approved in Italy, fills us with pride – says Salvatore Siena, professor of medical oncology at the University of Milan and director of the Department of Oncology of Niguarda – The goals achieved at the clinical and regulatory level by this made in Italy molecule are also an expression of the quality of Italian scientific research and the strong drive for innovation in our country, as well as being a fundamental result in the field of personalized medicine, which is broadening the prospects for treatment for thousands of cancer patients. “

Treatment has been shown to be effective in patients with different types of solid tumors, including sarcoma, non-small cell lung cancer, salivary gland mammary analogue secretory carcinoma (Masc), secretory and non-secretory breast cancer, thyroid cancer, colorectal, neuroendocrine, pancreatic, ovarian carcinoma, endometrial carcinoma, cholangiocarcinoma, gastrointestinal tumors and neuroblastoma including lung, colon, neuroblastoma and many other solid tumors.

“The versatility of entrectinib, even in light of its recent approval, can truly revolutionize treatment prospects for patients with advanced Ros1-positive non-small cell lung cancer and for patients with Ntrk-positive tumors. marked effectiveness allows it to be active at the level of the central nervous system, often the site of metastases that are difficult to treat, offering cancer patients new treatment options and an improvement in life expectancy “, remarks Silvia Novello, professor of medical oncology at University of Turin and president of Walce Onlus (Women Against Lung Cancer in Europe).

“Clinical trials – adds the expert – show how entrectinib produced a response in about 70% of patients with Nsclc Ros1-positive lung cancer, of which 35% had brain metastases, also showing a good profile of tolerability and handling, fundamental aspects for both clinicians and patients who can benefit from this oral therapy. For the correct and profitable use of this, as well as other targeted drugs, it is essential to identify the targets of action, carrying out genomic profiling tests that identify the mutations and genetic alterations on which to direct the most appropriate treatment “.


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