FDA Approves Lutetium Lu 177 Vipivotide Tetraxetan and Companion Diagnostic Agent for Metastatic, Castration-Resistant Prostate Cancer

On March 23, 2022, the FDA approved lutetium Lu 177 vipivotide tetraxetan (Pluvicto; Advanced Accelerator Applications USA, Inc, a Novartis company), a radioligand therapeutic agent, for the treatment of adult patients with prostate-specific membrane antigen (PSMA)–positive metastatic castration-resistant prostate cancer previously treated with an androgen receptor inhibitor and taxane-based chemotherapy.

In addition, the FDA approved gallium Ga 68 gozetotide (Locametz), the first-ever radioactive diagnostic agent approved for patient selection in the use of a radioligand therapeutic agent.

The efficacy of lutetium Lu 177 vipivotide tetraxetan was evaluated in the VISION trial, which demonstrated a statistically significant improvement over standard of care in the primary end points of overall survival (OS) and radiographic progression-free survival (rPFS).

The hazard ratio for OS was 0.62 (95% CI: 0.52 to 0.74; P <.001). Median OS was 15.3 months (95% CI: 14.2 to 16.9) with lutetium Lu 177 vipivotide tetraxetan and 11.3 months (95% CI: 9.8 to 13.5) with best standard of care.

Treatment with lutetium Lu 177 vipivotide tetraxetan may result in risk from radiation exposure, myelosuppression, and renal toxicity. Adverse reactions which occurred in at least 20% of patients were fatigue, dry mouth, nausea, anemia, decreased appetite, and constipation. The most common laboratory abnormalities that worsened from baseline in at least 30% of patients were decreased lymphocytes, decreased hemoglobin, decreased leukocytes, decreased platelets, decreased calcium, and decreased sodium.

However, the safety follow-up duration in VISION was not sufficient to capture late radiation-associated toxicities. Interpretation of the magnitude of the rPFS effect was limited due to a high degree of censoring from early drop out in the control arm.

Source:
US FOOD AND DRUG ADMINISTRATION: FDA approves Pluvicto for metastatic castration-resistant prostate cancer. News Release. FDA. March 23, 2022. Accessed April 5, 2022.