Novartis withdraws EMA application for adding new indication for Pluvicto

CAR-T Digest - August 2020

24 April 2026: Novartis withdraws EMA application for adding new indication for Pluvicto

Novartis announced that it has withdrawn its Type II variation application with the European Medicines Agency for Pluvicto in pre-chemotherapy PSMA-positive metastatic castration-resistant prostate cancer, following feedback from the Committee for Medicinal Products for Human Use
The withdrawal was driven by concerns related to the control arm used in the Phase 3 PSMAfore study, rather than any issues with the drug’s safety, efficacy, or quality
Importantly, the decision does not affect Pluvicto’s approved indications, ongoing clinical trials, or other regulatory submissions globally, and the therapy continues to be approved in key markets, including the United States, Japan, and China for this setting
Clinical evidence from the PSMAfore study remains supportive of Pluvicto’s benefit in this patient population and is reflected in recommendations from major international treatment guidelines such as ESMO, ASCO, EAU, and NCCN
Despite the setback in Europe, Novartis reiterated its commitment to advancing treatment options for patients with prostate cancer and continuing development efforts for Pluvicto across global markets