Thursday, Novartis AG (NYSE:NVS) shares are trading higher after the company confirmed plans to file for Pluvicto pre-taxane label expansion in the second half of 2024 based on data from its Phase 3 PSMAfore study.
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 eight months of follow-up, Pluvicto’s safety profile remains consistent with previous interim analyses presented in 2023.
Also Read: Novartis Agrees To Acquire German Blood Cancer-Drug Developer MorphoSys For €2.7B.
The Swiss pharmaceutical giant confirmed its plans to file in the second half of 2024 for a label expansion of Pluvicto for advanced prostate cancer for patients before receiving taxane-based chemotherapy.
In October 2023, Novartis delayed the regulatory submission for the label expansion from 2023 to 2024.
Pluvicto is approved in the U.S., the E.U., and other countries to treat adults with a type of advanced cancer called PSMA-positive mCRPC and who have already been treated with other anticancer treatments (ARPI and taxane-based chemotherapy).
In 2023, Novartis recorded $980 million from Pluvicto sales.
Price Action:Â NVS shares are up 2.98% at $97.18 on the last check Thursday.
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