Novartis Confirms Plans to File for Pluvicto® Pre-Taxane Label Expansion in H2 2024 Based on Latest Data from Phase III PSMAfore Study

Reno, Nevada (UroToday.com) -- Updated overall survival (OS) results from a pre-planned analysis at approximately 75% information fraction demonstrate 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: Novartis AG. (2024). Novartis Confirms Plans to File for Pluvicto® Pre-Taxane Label Expansion in H2 2024 Based on Latest Data from Phase III PSMAfore Study. [Press release]. https://www.novartis.com/news/novartis-confirms-plans-file-pluvicto-pre-taxane-label-expansion-h2-2024-based-latest-data-from-phase-iii-psmafore-study.

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