European Commission Approves 177Lu Vipivotide Tetraxetan Plus ADT for Prostate Cancer Subset

177Lu vipivotide tetraxetan becomes first targeted radioligand treatment approved by the European Commission for prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer.

The European Commission approved 177Lu vipivotide tetraxetan (Pluvicto) plus androgen deprivation therapy plus or minus androgen receptor (AR) pathway inhibition for the treatment of patients with prostate-specific membrane antigen (PSMA)–positive metastatic castration-resistant prostate cancer (mCRPC), according to a press release from Novartis.

The European Commission’s decision was based on findings from the phase 3 VISION trial (NCT03511664), which assessed treatment with 177Lu vipivotide tetraxetan plus best supportive care vs best supportive care alone. Data from the trial indicated that patients treated with 177Lu vipivotide tetraxetan experienced a 38% reduction in death, as well as a 60% statistically significant reduction in risk of radiographic disease progression or death vs best supportive care alone.

“Today’s approval of [177Lu vipivotide tetraxetan] 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,” Haseeb Ahmad, European president of Novartis, said in the press release.

177Lu vipivotide was approved by the FDA in March 2022 for the treatment of patients with PSMA-positive mCRPCwho were previously treated with an AR pathway inhibitor and taxane-based chemotherapy. The approval was also based on phase 3 data from the VISION trial.


Novartis receives European Commission approval for Pluvicto® as the first targeted radioligand therapy for treatment of progressive PSMA–positive metastatic castration-resistant prostate cancer. News release. Novartis. December 13, 2022. Accessed December 15, 2022.