Novartis’ Pluvicto (177Lu-PSMA-617) Received the US FDA’s Approval as the First Targeted Radioligand Therapy for Progressive, PSMA Positive mCRPC
Shots:
- The approval was based on a P-III (VISION) study that evaluates Pluvicto (7.4 GBq, IV infusion, q6w for a maximum of 6 cycles) + SOC vs SOC alone in a ratio (2:1) in 831 patients with PSMA+ mCRPC prior treated with AR pathway inhibition & taxane-based CT
- The results showed improvement in OS, 38% reduction in risk of death & reduction in risk of rPFS. Additionally, patients with evaluable disease at baseline demonstrated an overall response of 30% vs 2%
- Novartis anticipated the availability of Pluvicto to physicians and patients within weeks. The company is evaluating the therapy in two P-III studies in earlier lines of treatment for metastatic prostate cancer, intending to advance into earlier stages of the disease
Ref: Novartis | Image: Novartis
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