EMA application for adding new indication for Pluvicto withdrawn
Novartis has withdrawn a European Medical Agency type II variation application for Pluvicto to treat adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC)1 pre-chemotherapy, following CHMP feedback. The CHMP indicated that they would not support the application based on the control arm used in the PSMAfore study. The withdrawal is not related to the quality, efficacy or safety of Pluvicto and does not impact ongoing clinical trials, approved indications or pending regulatory submissions inside or outside the EU.
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