Pluvicto: A new treatment for prostate cancer

Pluvicto® from Novartis, an anti-metabolite, offers a new treatment option for prostate cancer patients.Find out here!

The Department of Health has approved funding in the National Health System for Novartis' Pluvicto® [lutetium (177Lu) vipivotide tetraxetane], the first and only radioligand (TRL) targeted therapy for the treatment of advanced metastatic castration-resistant prostate cancer (mCRPC) in adult patients positive for anti-MB-SPMS-specific MA.Funding and indication is for patients who have received treatment with androgen receptor (AR) pathway inhibitors and two-line taxane chemotherapy, or for patients ineligible for second-line taxane chemotherapy in combination with androgen deprivation therapy (ADT) or without AR pathway inhibitors.

Its approval is supported by the results of the phase III trial of VISION, in which it met the primary objectives of overall survival or mortality of 60%, comparable and mortality with standard care.

High prevalence of prostate cancer

Prostate cancer is a leading cause of cancer death in men, especially those over 50 years of age.This type of cancer is a major public health problem due to its high prevalence.In its advanced form, prostate cancer can spread to other parts of the body, making it a more complicated disease to treat.In fact, the five-year survival of people with mCRPC is approximately 15%, demonstrating the immense need for targeted solutions for these patients.

An alternative to improve patients' quality of life

Limited therapeutic options, treatment resistance, and disease burden remain major public health priorities related to mCRPC.In this context, this therapeutic innovation offers a new approach that changes the way this cancer is treated, bringing new hope to patients by offering a more precise and effective option.In addition to the clinical benefit, this treatment contributes to improving the quality of life of patients, while opening the door to a new paradigm in oncological treatment based on precision and targeted medicine.

What does therapy consist of?

The treatment combines a targeted compound (ligand, in this case targeting PSMA) with a therapeutic radioisotope (a radioactive material, in this case lutetium-177), which acts directly on cancer cells that express PSMA, a biomarker present in more than 80% of prostate cancers.

Dr.Aránzazu González del Alba, president of the Spanish Genital Oncology Group (SOGUG) and specialist in medical oncology from the University Hospital of Puerta de Hierro Majadahonda, explains that "this new treatment marked a fundamental change in the treatment of metastatic castration-resistant prostate cancer. It is a treatment based on a specific treatment concept that consists of a precise treatment concept based on the protein concept, PSMA."PSMA, which is expressed by most prostate tumor cells. With a PET test with a radiopharmaceutical, we can detect all diseases that express this membrane protein, PSMA, and with another radiopharmaceutical, lutetium-177 PSMA, target the treatment specifically to those tumor cells with a very favorable safety profile."

Benefits of the new treatment

Regarding the benefits, Dr. González del Alba states that "it has managed to increase overall survival and life expectancy, delay progression, achieve tumor response and, in addition, improve quality of life and relieve pain and, therefore, improve the functional status of patients."In this sense, "the main challenge is that all patients who have the appropriate profile and who are at the stage of the disease where treatment is indicated can access this therapeutic innovation, regardless of the geographical area where they are."

Dr.Virginia Pubul Núñez, President of the Spanish Society of Nuclear Medicine and Molecular Imaging (SEMNIM) and Head of the Nuclear Medicine Service at the University Hospital Complex of Santiago de Compostela (CHUS), states that this treatment "represents a decisive advance for nuclear medicine, which assumes an important role in its individual medicine. additional treatment by selecting patients based ontumor biology and offering targeted therapy that optimizes clinical benefit and quality of life."

Dr. Pablo Maroto, President of the GUARD Consortium and Director of the Medical Oncology Service at Santa Creu i Sant Pau Hospital, explains, "The VISION study shows that this treatment improves the survival of hormonal therapy and chemotherapy given to patients with metastatic prostate cancer. We are practically a treatment line with excellent tolerance for patients who have "exhausted available treatments".

Consolidating TRL as a new paradigm in prostate cancer

Introducing a new paradigm in the cancer approach, TRLs represent an innovative targeted therapy approach based on nuclear medicine that combines diagnosis and treatment.TRLs combine a specific compound (ligand) with a radioactive particle (radioisotope).After intravenous administration, the muscle directs the radioactive isotope to the tumor cells.This mechanism directly attacks the cancer, improving the effectiveness of the treatment and reducing the side effects.

Unlike other conventional treatments such as chemotherapy, LRT offers targeted radiation that works more locally and minimizes the impact on surrounding healthy tissue.Combining diagnosis and treatment on one platform not only optimizes accuracy, but also improves quality of life during and after treatment.TLR has shown improvements in survival, time to disease progression, and quality of life in many people living with mCRPC.

Radiopharmacy, a strategic specialty

Dr.Juan Antonio Pérez Iruela, President of the Spanish Radiopharmaceutical Society (SERFA) and pharmacist specializing in radiopharmaceuticals at the Ramón y Cajal Hospital, noted that "the combination of diagnostics and treatments (teragnosis) in a single platform redefines clinical practice and opens up

it opens up future use in other types of cancer. In addition, this method "integrates radiopharmacy as a technique in oncological treatment and clinical decision-making".

In this context, Spain occupies a strategic position in the development and production of LRTs, delivering the largest number of patients to clinical development programs in Europe and making Zaragoza one of the company's five centers capable of manufacturing these treatments. Our production center in La Almunia de Dona Godina has 100 employees and plays a key role in the production and supply of these solutions to the world. In 2025, the total investment in the plant will reach 53 million euros.

Lupe Martinez, Medical Director of Novartis, said: “At Novartis, we are rethinking the way we treat cancer by offering innovative treatments that go beyond conventional LRT. We combine diagnosis and treatment into one focused strategy.It selectively attacks tumor cells with a new treatment option in Spain,” providing advanced therapy that improves survival and transforms their quality of life.