Tumors, green light for a new “made in Italy” molecule for adults and children – time.news

by time news
from V. March.

Very useful for fighting different forms of cancer that share the same DNA mutation, that of the NTRK or ROS1 genes. Also effective against brain metastases

Well tolerated, without serious side effects, very useful for fighting various forms of cancer. A drug that is the result of “made in Italy” research has been approved by the Italian Medicines Agency (Aifa) for marketing and reimbursement in dual indication, both as a drug with a molecular target and as an agnostic therapy, that is, it acts on genetic alteration present in the tumor, regardless of the affected organ. Entrectinib, this is the name of the drug, was presented among the most promising innovations during the congress of the American Association for Cancer Research (AACR) five years ago and was developed thanks to the joint work of the laboratories of the Nerviano Medical Sciences and the Milanese researchers from the National Cancer Institute and the Niguarda Cancer Center.

An effective drug against many different cancers

In several studies that led to approval, the treatment has been shown to be effective in patients with different types of solid tumors, including sarcoma, non-small cell lung cancer, mammary analogue secretory carcinoma (MASC) of the salivary glands, carcinoma of the secretory and non-secretory breast, thyroid tumors, colorectal, neuroendocrine, pancreatic, ovarian, endometrial carcinoma, cholangiocarcinoma, gastrointestinal tumors and neuroblastoma including lung, colon, neuroblastoma and many other solid tumors. “Patients suitable for treatment must in fact be identified through a molecular screening of the tumor: if the NTRK or ROS1 mutations on which the medicine was” built “are present, then the treatment is carried out – explains Filippo de Braud, Full Professor of Oncology University of Milan and Director of the Department of Medical Oncology and Hematology IRCCS Foundation National Cancer Institute of Milan -. The agnostic indication consists precisely in this: we are no longer based on the organ affected by the tumor, but on the genetic alteration that distinguishes it. You hit a very specific target. 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. Furthermore, thanks to the fact that the drug penetrates the blood brain barrier, good rates of intracranial response are obtained, higher than 50% in the presence of brain metastases ».

Green light for adults and children

Specifically, Aifa’s go-ahead for entrectinib has arrived for adult patients with ROS1-positive advanced non-small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors and for the treatment of adult and pediatric patients of age or age. over twelve years with solid tumors expressing a fusion of neurotrophic receptor tyrosine kinase (NTRK) genes. “The goals achieved at a 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 expanding the prospects for treatment for thousands of cancer patients – comments Salvatore Siena, Professor of Medical Oncology at the University of Milan and director of the Oncology Department of the Niguarda Hospital -. It is in fact a tyrosine kinase inhibitor capable of blocking the kinase activity of the ROS1 and NTRK genes and favoring the necrosis of cancer cells. And, very importantly, several trials that led to its approval indicate that it was well tolerated, with adverse events that were not serious and infrequent ».

Also effective against brain metastases

Knowing the DNA mutations present in a patient’s neoplasm is fundamental today to identify specific alterations that can guide therapeutic choices: target therapies, in fact, can only be used if the presence of specific markers is detected. To establish which is the most effective treatment for a patient, it is necessary to have the interpretation of the genomic profile of a tumor and the techniques used to perform these analyzes are numerous, complex and very sophisticated: ranging from immunohistochemistry to immuno-pheno-typing. , from in situ hybridization to cytogenetics, from Sanger sequencing methods to mass spectrometry and next generation sequencing (NGS) methods. “Knowing whether or not a tumor has a certain genetic mutation can make a big difference – underlines Silvia Novello, Professor of Medical Oncology at the University of Turin and President of WALCE Onlus (Women Against Lung Cancer in Europe) -. The versatility of entrectinib can truly revolutionize treatment prospects for patients with ROS1-positive advanced non-small cell lung cancer and for patients with NTRK-positive tumors. Its marked efficacy allows it to be active in 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. Clinical trials show how entrectinib produced a response in about 70% of patients with ROS1-positive NSCLC lung cancer of which 35% had brain metastases, also showing a good profile of tolerability and manageability, fundamental aspects for both clinicians. both for patients who can benefit from this oral therapy ».

September 15, 2021 (change September 15, 2021 | 14:19)

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