On April 24, 2026 Novartis reported it has withdrawn a European Medical Agency type II variation application for Pluvicto to treat adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic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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Importantly, the PSMAfore study that supported the application, was the basis for successful approval of Pluvicto in pre-chemotherapy mCRPC patients in the United States, Japan, and China. The value of Pluvicto in this population is also reflected in evidence-based recommendations from leading professional guidelines, including ESMO (Free ESMO Whitepaper), EAU, ASCO (Free ASCO Whitepaper) and NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines)2.

We are disappointed by this outcome and remain committed to advancing treatment options for people with prostate cancer.

(Press release, Novartis, APR 24, 2026, View Source [SID1234664748])