Novartis confirms plans to file for Pluvicto® pre-taxane label expansion in H2 2024 based on latest data from Phase III PSMAfore study

Novartis confirms plans to file for Pluvicto® pre-taxane label expansion in H2 2024 based on latest data from Phase III PSMAfore study

Apr 04, 2024

Updated overall survival (OS) results from a pre-planned analysis at approximately 75% information fraction demonstrates an OS hazard ratio less than 1.0 (HR<1.0) in the intent-to-treat (ITT) population unadjusted for cross-over.

Radiographic progression free survival (rPFS) and other secondary efficacy endpoints are consistent with previous interim analysis results presented in 2023.

With an additional 8 months of follow-up, Pluvicto® safety profile remains consistent with previous interim analyses presented in 2023.

Full results will be presented at an upcoming medical congress.

Novartis confirms plans to file in H2 2024.


Source URL: https://www.novartis.com/news/novartis-confirms-plans-file-pluvicto-pre-taxane-label-expansion-h2-2024-based-latest-data-from-phase-iii-psmafore-study

List of links present in page
  1. https://www.novartis.com/news/novartis-confirms-plans-file-pluvicto-pre-taxane-label-expansion-h2-2024-based-latest-data-from-phase-iii-psmafore-study