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He Ministry of Health has approved the financing of Pluvicto (lutetium (177Lu) vipivotide tetraxetan) Novartisthe first and only radioligand-targeted therapy for the treatment of adult patients with metastatic prostate cancer progressive castration-resistant (mCRPC) positive for prostate-specific membrane antigen (PSMA).
The therapy is indicated in patients previously treated with androgen receptor (AR) inhibitors and two lines of taxane chemotherapy, or ineligible for a second line of taxane, in combination with androgen deprivation therapy.
He Prostate cancer is one of the main causes of cancer death in men, especially in people over 50 years of age, and in its advanced phase it can spread to other organs. In the case of mCRPC, five-year survival is around 15%, which highlights an important unmet medical need and the priority of incorporating new effective therapeutic options.
Radioligand-targeted therapies represent a new approach based on precision oncology, by combining diagnosis and treatment and acting selectively on tumor cells that express PSMA, a biomarker present in more than 80% of prostate cancers. This strategy makes it possible to directly attack cancer cells, reducing the impact on healthy tissue and improving the safety profile. Beyond the clinical benefit, this therapy contributes to improving the quality of life of patients and opens the door to a new paradigm in oncological treatment.
The doctor Aránzazu González del Albapresident of Spanish Genitourinary Oncology Group (SOGUG) and specialist in Medical Oncology at the Puerta de Hierro Majadahonda University Hospital, explains that “through a PET test with a radiopharmaceutical, we can detect all the disease that expresses that membrane protein, PSMA, and with another radiopharmaceutical, lutetium-177 PSMA, direct a treatment towards those tumor cells specifically and with a very favorable safety profile. In such a way that we treat what we see and we see what we treat”
The specialist highlights that Pluvicto “has managed to increase overall survival and life expectancy, delay progression, achieve a tumor response and improve quality of life and relieve pain”, and adds that the main challenge is that “all patients who have the appropriate profile and are at the stage of the disease where treatment is indicated can access this therapeutic innovation regardless of the geographical area.”
The doctor Virginia Pubul Núñez, president of the Spanish Society of Nuclear Medicine and Molecular Imaging (SEMNIM) and head of the Nuclear Medicine Service of the Santiago de Compostela University Hospital Complex (CHUS) points out that this treatment “represents a decisive advance for nuclear medicine, which assumes a central therapeutic role in oncology, and reinforces multidisciplinary collaboration. In addition, it allows greater personalization of treatment, by selecting patients based on tumor biology and offering a targeted therapy that optimizes clinical benefit and quality of life.”
The approval of Pluvicto is supported by the results of the phase III VISION trial, in which it met the primary objectives of overall survival (OS) and radiological progression-free survival (RFS), reducing the risk of death by 38% and the risk of radiological progression or death by 60%, compared to standard of care.
The doctor Pablo Maroto, president of GUARD Consortium and director of the Medical Oncology Service of the Hospital de la Santa Creu i Sant Pau, explains that “this therapy administered in patients with metastatic prostate cancer who have progressed to hormonal treatments and chemotherapy improves survival compared to the available treatment”, with “a low toxicity profile and little severity”, offering “a new effective therapeutic line with excellent tolerance for patients for whom in practice the available treatments had been exhausted”.
Spain occupies a strategic position in the development and production of radioligand therapies, being the European country that has contributed the most patients to clinical development programs and hosting in Zaragoza one of the company’s five centers in the world with the capacity to produce these treatments. The La Almunia de Doña Godina plant, with more than 100 workers, plays a key role in its global manufacturing and supply and has consolidated a total investment of 53 million euros in 2025.
Lupe Martínez, Medical Director of Novartis, indicated that “at Novartis we are reimagining the approach to cancer by leading the introduction of innovative therapeutic platforms that go beyond conventional approaches. With radioligand therapies we combine diagnosis and treatment in a single precision strategy that selectively attacks tumor cells, offering new possibilities where there were few options before.”
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