Originally published by our sister publication Clinical Oncology News
By Clinical Oncology News Staff
The FDA expanded the indication for lutetium Lu 177 vipivotide tetraxetan (Pluvicto, Novartis) to include adults with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor pathway inhibitor (ARPI) therapy and are considered appropriate to delay taxane-based chemotherapy.
Patients with previously treated mCRPC should be selected for lutetium Lu 177 vipivotide tetraxetan using Locametz (active ingredient gallium Ga 68 gozetotide, also Novartis) or another approved PSMA PET product based on PSMA expression in tumors.
Efficacy was evaluated in PSMAfore (ClinicalTrials.gov Identifier: NCT04689828), a randomized, multicenter, open-label trial enrolling 468 patients with PSMA-positive mCRPC and progression on one ARPI, who the investigator considered appropriate for delay of taxane-based chemotherapy. Patients were randomized (1:1) to receive lutetium Lu 177 vipivotide tetraxetan (7.4 GBq [200 mCi] every six weeks for six doses) or a change in ARPI. Patients who progressed on the ARPI arm were allowed to cross over to the experimental therapy.
The major efficacy outcome was radiographic progression-free survival (rPFS) by blinded independent central review. Overall survival (OS) was an additional efficacy outcome. Median rPFS was 9.3 months (95% CI, 7 months to not estimable) in the lutetium Lu 177 vipivotide tetraxetan arm and 5.6 months (95% CI, 4-6 months) in the ARPI arm (hazard ratio [HR], 0.41; 95% CI, 0.29-0.56; P<0.0001). Median OS was 24.5 months (95% CI, 19.5-28.9 months) and 23.1 months (95% CI, 19.6-25.5 months) in the respective arms (HR, 0.91; 95% CI, 0.72-1.14); the P value was not statistically significant. Sixty percent (n=141) of patients who were randomized to receive a change in ARPI crossed over to receive lutetium Lu 177 vipivotide tetraxetan after progression.
Adverse reactions were consistent with prior experience with lutetium Lu 177 vipivotide tetraxetan. Treatment with lutetium Lu 177 vipivotide tetraxetan may result in risk from radiation exposure, myelosuppression and renal toxicity.
The full prescribing information for lutetium Lu 177 vipivotide tetraxetan will be posted on Drugs@FDA.
Based on a press release from the FDA.
