Novartis gets Pluvicto EC approval for advanced prostate cancer

Novartis has received the approval of the European Commission (EC) for Pluvicto (lutetium (177Lu) vipivotide tetraxetan), a targeted radioligand therapy for advanced prostate cancer.

Following the approval, Pluvicto has become the first targeted radioligand therapy to be commercially available to prevent advanced prostate cancer in individuals.

Pluvicto in combination with androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition is approved for the treatment of adult patients with prostate-specific membrane antigen (PSMA)–positive metastatic castration-resistant prostate cancer (mCRPC).

Novartis said that the Pluvicto EC approval was backed by the findings from the VISION phase 3 trial, where the intravenous radioligand candidate plus best standard of care (BSoC) significantly improved overall survival and radiographic progression-free survival in patients with pre-treated PSMA–positive mCRPC.

Novartis bags Pluvicto EC approval for advanced prostate cancer. Photo courtesy of Novartis AG.

Haseeb Ahmad — Novartis Europe President, commenting on Pluvicto EC approval, said: “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.

“We are excited by the potential of Pluvicto to bring groundbreaking clinical benefits to these patients, transforming cancer care for the third-most diagnosed cancer globally.”

The randomized, open-label and multicenter VISION trial evaluated the efficacy and safety of Pluvicto, 7.4 GBq administered by IV infusion every six weeks for a maximum of 6 cycles, plus investigator-chosen standard of care (BSoC) in the investigational arm, versus BSoC in the control arm.

Pluvicto is also being evaluated in additional phase 3 trials for treatment in earlier stages of metastatic prostate cancer.

Novartis is also assessing prospects to study Pluvicto radioligand therapy in earlier stages of prostate cancer.

In 2020, Europe registered around 473,300 prostate cancer cases and 108,000 prostate cancer-related deaths.

Pluvicto is approved in the US, Canada, and the UK for the treatment of adults with advanced prostate cancer.