JOURNAL ARTICLE

FDA Expands Radiopharmaceutical's Metastatic Castration-Resistant Prostate Cancer Indication.

  • Published In: ONS Voice, 2025. P. N.PAG 1 of 2

  • Database: Academic Search Ultimate 2 of 2

Abstract

The article focuses on the U.S. Food and Drug Administration's (FDA) expanded approval of lutetium Lu 177 vipivotide tetraxetan (Pluvicto®) for adults with prostate-specific membrane antigen (PSMA)–positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor pathway inhibitor (ARPI) therapy and are suitable to delay taxane-based chemotherapy. This approval is based on the PSMAfore trial, which demonstrated improved radiographic progression-free survival compared to a change in ARPI, though overall survival differences were not statistically significant. Patients must be selected for treatment using PSMA positron-emission tomography products such as gallium Ga 68 gozetotide (Locametz®). Adverse reactions align with known effects of lutetium Lu 177 vipivotide tetraxetan, including radiation exposure, myelosuppression, and renal toxicity.

Additional Information

  • Source:ONS Voice. 2025/03, pN.PAG
  • Document Type:Article
  • Subject Area:Health and Medicine
  • Publication Date:2025
  • ISSN:2475-6938
  • Accession Number:184129516
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