Tumors, mutation count not affected organ: ok Aifa to agnostic therapy 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 world 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 “.