India, April 24 -- Novartis (NVS) has withdrawn its European Medical Agency (EMA) application seeking to expand the use of Pluvicto in prostate cancer, after regulators signaled, they would not support the submission based on the study design used.
The company has applied for a type II variation to add a new indication for PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) patients prior to chemotherapy. However, the Committee for Medicinal Products for Human Use (CHMP) advised that it could not endorse the application due to concerns about the control arm used in the PSMAfore study, which supported the filing.
Novartis emphasized that the withdrawal is not related to the quality, efficacy, or safety of Pluvicto, and do...