Posted by Michael Wonder on 25 Apr 2026
Novartis withdraws EMA application for adding new indication for Pluvicto
24 April 2026 - Novartis has withdrawn a EMA type II variation application for Pluvicto to treat adult patients with prostate-specific membrane antigen positive metastatic castration-resistant prostate cancer 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.
