Pluvicto Approved in Spain for Advanced Prostate Cancer
Spain has approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan), a groundbreaking targeted radiotherapy, for the treatment of prostate cancer. Specifically, it’s indicated for adult patients wiht prostate cancer that has spread to other parts of the body (metastatic castration-resistant prostate cancer or mCRPC) and is positive for prostate-specific membrane antigen (PSMA).This approval represents a meaningful advancement in treatment options for men with advanced prostate cancer in Spain.
What is Pluvicto and How Does it work?
Pluvicto is a radioligand therapy. This means it combines a radioactive isotope (lutetium-177) with a molecule (vivotide tetraxetan) that specifically targets PSMA. PSMA is a protein found in high levels on the surface of most prostate cancer cells.
The therapy works in the following way:
- Targeting: The radioligand binds to the PSMA on prostate cancer cells.
- radiation Delivery: Once bound, the lutetium-177 emits beta particles, which deliver a localized dose of radiation directly to the cancer cells.
- minimized Damage: As the radiation is targeted, it aims to spare healthy tissues, reducing side effects compared to traditional chemotherapy or radiotherapy.
Approval and Clinical Trial Data
The approval of Pluvicto in Spain follows positive results from the Phase 3 PSMAfore study novartis. The study demonstrated that Pluvicto, in combination with standard of care, substantially improved overall survival compared to standard of care alone. Specifically, patients treated with Pluvicto experienced a 37% reduction in the risk of death.
The therapy received conditional marketing authorisation in the European Union in December 2022, and has since been approved in numerous countries. The approval in Spain makes it accessible to a broader range of patients.
Who is Eligible for Pluvicto Treatment?
Pluvicto is indicated for adult patients with mCRPC who meet the following criteria:
- Their prostate cancer has spread to other parts of the body (metastatic disease).
- They are resistant to treatments that lower testosterone (castration-resistant).
- Their cancer cells express PSMA, which can be steadfast through a PSMA PET/CT scan.
potential Side effects
As with any cancer treatment, pluvicto can cause side effects. Common side effects include:
- Fatigue
- Nausea
- Anemia (low red blood cell count)
- Thrombocytopenia (low platelet count)
- Dry mouth
Serious side effects are rare, but can include bone marrow suppression and kidney problems. Patients will be closely monitored during and after treatment to manage any side effects.
Access in Spain
Pluvicto’s arrival in spain provides a new hope for patients battling advanced prostate cancer. The availability of this innovative therapy underscores Spain’s commitment to providing access to cutting-edge cancer treatments. Availability and reimbursement details will vary by region within Spain.
Key Takeaways
- Pluvicto is a first-in-class radioligand therapy for PSMA-positive mCRPC.
- It delivers targeted radiation to cancer cells,minimizing damage to healthy tissues.
- Clinical trials have shown significant improvements in overall survival.
- Treatment is available for eligible patients with advanced prostate cancer in Spain.
Date of Publication: 2026/01/14 19:30:04
