Spain Approves Pioneering Targeted Radioligand Therapy for Advanced Prostate Cancer

Spain has officially approved Pluvicto, the first targeted radioligand therapy for metastatic prostate cancer, improving survival and quality of life for patients with advanced disease.

    Key details

  • • Spain's Ministry of Health funds Pluvicto, the first targeted radioligand therapy for metastatic castration-resistant prostate cancer (CPRCm) positive for PSMA.
  • • The phase III VISION trial showed a 38% reduction in death risk and 60% reduction in progression or death risk.
  • • The therapy enhances patient survival and quality of life by targeting cancer cells with radioactive isotopes, sparing healthy tissue.
  • • Spain plays a key role in TRL production with a facility in Zaragoza and a €53 million investment.
  • • Experts highlight the paradigm shift in personalized cancer treatment through the theragnosis concept combining diagnosis and treatment.

The Spanish Ministry of Health has approved and funded Pluvicto (lutetium-177 vipivotide tetraxetan), marking a significant advancement as the first targeted radioligand therapy (TRL) for adults with metastatic castration-resistant prostate cancer (CPRCm) positive for prostate-specific membrane antigen (PSMA). This innovative treatment, developed by Novartis, is indicated for patients who have progressed after androgen receptor inhibitors and taxane chemotherapy or those ineligible for further taxane treatment, used alongside androgen deprivation therapy.

CPRCm poses a major health challenge with a five-year survival rate of approximately 15%. Pluvicto offers hope by integrating a PSMA-targeting ligand with a radioactive isotope, lutetium-177, which selectively attacks cancer cells while sparing healthy tissue. Clinical evidence from the phase III VISION trial demonstrates a 38% reduction in mortality risk and a 60% reduction in progression or death risk compared to standard therapies.

Experts underscore the therapy's impact on improving survival and quality of life. Dr. Aránzazu González del Alba described it as a transformative shift in managing CPRCm by focusing precisely on a tumor biomarker, while Dr. Virginia Pubul Núñez emphasized its role in advancing personalized nuclear medicine. The concept of "theragnosis," combining diagnosis and treatment as noted by Dr. Juan Antonio Pérez Iruela, introduces a new paradigm in cancer care.

Spain is also a strategic hub in TRL development and production, with a major facility in Zaragoza employing over 100 people and backed by a €53 million investment by 2025. Novartis’ Lupe Martínez highlighted the potential for innovative platforms integrating diagnosis and therapy, envisioning new treatment avenues for patients facing limited options after conventional treatments.

This article was synthesized and translated from native language sources to provide English-speaking readers with local perspectives.