Pluvicto® pre-taxane label expansion filing planned in H2 2024 based on latest data from Ph 3 PSMAfore study
“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. Novartis confirms plans to file in H2 2024.”
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