The Swiss pharmaceutical group Novartis announces the EU green light for the first precision radioligand therapy for the treatment of the most difficult forms of prostate cancer. The European Commission has indeed approved Pluvicto* (Lutetium vipivotide tetraxetan) in combination with androgen deprivation therapy (ADT), with or without androgen receptor (AR) pathway inhibition, for the treatment of adult patients with metastatic cancer-resistant prostate cancer. castration (mCrpc), progressive and positive for prostate specific membrane antigen (Psma). These patients had already been treated with AR pathway inhibitor and taxane-based chemotherapy. The Commission’s green light follows the positive opinion expressed in October by the Committee for Medicinal Products for Human Use of the European Medicines Agency EMA and is applicable to all 27 Member States of the European Union, as well as Iceland, Norway, Northern Ireland North and Liechtenstein.
The CE approval – explains Novartis – was granted on the basis of the results of the pivotal phase III Vision study, during which the participants, previously treated with Ar pathway inhibition and taxane-based chemotherapy, who had received Lutetium vipivotide tetraxetan plus best standard of care (BSOC) showed a 38% reduction in the risk of death and a statistically significant (-60%) reduction in the risk of radiographic disease progression or death (rPFS), compared with BSOC alone. Approximately one-third (30%) of patients with evaluable disease at baseline demonstrated an objective response with lutetium vipivotide tetraxetan plus BSOC, compared with 2% in the BSOC alone arm.
“Treatment with radioligands opens up new perspectives in terms of treatment for prostate cancer, one of the most widespread in the world – says Sergio Bracarda, president of Siuro – It is important to underline that it is a completely new, which combines a radioisotope with a molecule capable of recognizing and binding to a receptor expressed on tumor cells and capable of overcoming both innate and induced resistances from previous treatments, while demonstrating a significant advantage in terms of survival”.
“More than 80% of patients with metastatic prostate cancer express the specific prostate membrane antigen therapeutic target for therapy with Lutetium vipivotide tetraxetan – underlines Marcello Tucci, director of the Asl Oncology Structure of Asti – Coming soon, following completion of the price and reimbursement process, these patients will also be able to benefit from this valid treatment option in Italy”.
“The approval of Lutetium vipivotide tetraxetan, the first targeted therapy with radioligands, by the European Commission – declares Valentino Confalone, Country President of Novartis Italia – represents a significant milestone for patients with advanced and metastatic prostate cancer, which up to today they had a limited number of treatments in this stage of the disease. We are proud as Novartis to help reimagine the perspectives of care for patients with prostate cancer and we look forward to making it available to Italian patients soon”. Additional phase III trials are currently underway to evaluate lutetium vipivotide tetraxetan for the early treatment of metastatic prostate cancer. The Basel-based company is developing a broad portfolio of radioligand therapies for the treatment of cancer and is investing in production capacity to meet the growing demand for treatment globally.
In 2020, there were approximately 473,300 cases of prostate cancer in Europe, with 108,000 disease-related deaths – Novartis recalls – Patients with metastatic prostate cancer have an approximately three in 10 chance of surviving 5 years, indicating a high unmet need for new targeted therapeutic options. The Rhenish multinational is committed to responding to this need by redesigning cancer treatment through radioligand therapy and precision medicine, with the aim of reducing the global disease burden, prolonging the life of patients with prostate cancer and raising the current standards of care.
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