Novartis radioligand therapy Pluvicto gets approval in EU for advanced prostate cancer

Alexis Juanita

European union flag against parliament in Brussels


The European Commission (EC) approved Novartis (NYSE:NVS) Pluvicto to treat certain patients with advanced prostate cancer.

The radioligand therapy was approved in combination with androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition to treat adult patients with prostate-specific membrane antigen (PSMA)–positive metastatic castration-resistant prostate cancer (mCRPC).

These patients have been treated with AR pathway inhibition and taxane-based chemotherapy.

The EC approval follows a positive opinion by a panel of the European Medicines Agency in October to approve Pluvicto (INN: lutetium (177Lu) vipivotide tetraxetan).

The Swiss pharma giant said Pluvicto became the first targeted radioligand therapy commercially available for people with advanced prostate cancer.

The approval was backed by data from a phase 3 trial called VISION.

Novartis noted that it is also evaluating opportunities to investigate Pluvicto radioligand therapy in earlier stages of prostate cancer.

Earlier in December, the drug met the main goal of a phase 3 study, dubbed PSMAfore in patients with a type of prostate cancer.

Pluvicto is already approved in the U.S. and other countries including the U.K. and Canada to treat adults with prostate-specific membrane antigen (PSMA)–positive mCRPC who have already been treated with other anticancer therapies.

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