Novartis withdraws EU filing for Pluvicto label expansion into early-stage prostate cancer

Novartis announced it has pulled its application to the European Medicines Agency to extend the label of its radioligand therapy Pluvicto for use in earlier stages of prostate cancer.

The move comes after the drug already received approval for the same indication in the United States and the United Kingdom, where regulators have accepted the data supporting the broader use.

European regulators had not yet granted the extension, and the company decided to discontinue the filing rather than continue the review process.

The withdrawal does not affect the existing approved indication for advanced prostate cancer in the EU, and patients currently treated with Pluvicto will continue to have access under the current label.