Novartis Withdraws Request to Expand Indication for Pluvicto

Novartis has withdrawn its application to the European Medicines Agency (EMA) seeking approval to expand the indication for Pluvicto to treat adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) prior to chemotherapy.

The withdrawal follows feedback from the Committee for Medicinal Products for Human Use (CHMP), which indicated it would not support the application due to concerns about the control arm used in the PSMAfore study that underpinned the submission.

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 pending regulatory submissions within or outside the European Union.

The PSMAfore study, which formed the basis of the EMA application, previously supported successful approvals of Pluvicto for pre-chemotherapy mCRPC in the United States, Japan, and China. The therapy’s value in this patient population is also reflected in evidence-based recommendations from major oncology guidelines, including those from ESMO, EAU, ASCO, and the NCCN Clinical Practice Guidelines in Oncology.

The withdrawn application was intended for adult patients with mCRPC who are asymptomatic or mildly symptomatic after progressing on androgen receptor pathway inhibitor (ARPI) therapy and for whom chemotherapy is not yet clinically indicated.

Pluvicto, known scientifically as lutetium Lu 177 vipivotide tetraxetan, is an intravenous radioligand therapy that combines a PSMA-targeting ligand with the therapeutic radionuclide lutetium-177. It is currently approved for use in patients with PSMA-positive mCRPC who have received prior ARPI and taxane-based chemotherapy.

The company remains committed to advancing treatment options for people with prostate cancer and continues to pursue regulatory pathways for Pluvicto in other indications and regions.