By Mauro Orru

The European Commission, the executive arm of the European Union, approved Novartis AG's Pluvicto radioligand therapy to treat people with advanced prostate cancer.

The Swiss pharmaceutical company said Tuesday that the approval, based on results from a Phase 3 trial, is for Pluvicto in combination with androgen deprivation therapy with or without androgen receptor pathway inhibition.

The green light makes Pluvicto the first targeted radioligand therapy to treat adult patients with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer.

"Today's approval of Pluvicto by the European Commission marks a major milestone for patients with advanced prostate cancer who have few alternative treatments at this stage of their disease," said Novartis's President for Europe Haseeb Ahmad.

Novartis said further Phase 3 trials are underway to assess Pluvicto for treatment in earlier stages of metastatic prostate cancer.

Write to Mauro Orru at mauro.orru@wsj.com; @MauroOrru94

(END) Dow Jones Newswires

December 13, 2022 01:46 ET (06:46 GMT)

Copyright (c) 2022 Dow Jones & Company, Inc.
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