Novartis (NVS) has withdrawn its European Medical Agency (EMA) application seeking to expand the use of Pluvicto in prostate cancer, after regulators signaled, they would not support the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 does not affect ongoing clinical trials, approved indications, or regulatory submissions in or outside the EU. The company noted that the same PSMAfore data formed the basis for successful approvals in the United States, Japan, and China, and is reflected in recommendations from leading oncology guidelines, including ESMO, EAU, ASCO, and NCCN.
"We are disappointed by this outcome and remain committed to advancing treatment options for people with prostate cancer," Novartis stated.
The original submission targeted adults with mCRPC who are asymptomatic or mildly symptomatic after progressing on an androgen receptor pathway inhibitor (ARPI) and for whom chemotherapy is not yet clinically indicated.
NVS has traded between $104.93 and $170.46 over the past year. The stock is currently trading at $145.34, down 1.45%.
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April 24, 2026 15:15 ET Economics news flow was relatively light this week even as the conflict in the Middle East continued, raising concerns for policymakers. In the U.S., spending data, initial jobless claims and pending home sales were the highlights. Business confidence in the biggest euro area economy was in focus in Europe. Inflation data from Japan gained attention in Asia.