Novartis withdraws EU application for Pluvicto in pre-chemotherapy prostate cancer after Committee for Medicinal Products for Human Use raises concerns over trial design.
Written By: Mahathi Palivela, PharmD
Reviewed By: Pharmacally Editorial Team
Novartis has withdrawn its Type II variation application to the European Medicines Agency for Pluvicto in adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer prior to chemotherapy.
The decision follows feedback from the Committee for Medicinal Products for Human Use (CHMP).
The CHMP indicated it would not support the application due to concerns with the control arm used in the PSMAfore study. This study formed the basis of the regulatory submission. Novartis clarified that the withdrawal is not related to the quality, efficacy, or safety of Pluvicto.
It also does not affect ongoing clinical trials, existing approvals, or other regulatory submissions globally.
The PSMAfore study has supported approvals of Pluvicto in the same pre-chemotherapy setting in the United States, Japan, and China.
Its clinical value is also reflected in recommendations from leading guidelines, including the European Society for Medical Oncology, European Association of Urology, American Society of Clinical Oncology, and National Comprehensive Cancer Network.
Novartis stated it is disappointed with the outcome. The company added that it remains committed to advancing treatment options for patients with prostate cancer.
References
Novartis Withdraws EMA Application for Adding New Indication for Pluvicto, Apr 24, 2026 https://www.novartis.com/news/novartis-withdraws-ema-application-adding-new-indication-pluvicto
About the Writer
Mahathi Palivela is pursuing PharmD and has a strong interest in Clinical Pharmacy and Patient safety. She is passionate about handling and analyzing patient data, and translating clinical insights into clear, meaningful summaries. She aims to apply this interest in Medical Writing and Pharmacovigilance, focusing on improving patient outcomes through careful data interpretation and communication.