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

On April 4, 2024 Novartis reported 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 (Press release, Novartis, APR 3, 2024, View Source [SID1234641784]).

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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.