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Novartis’ Pluvicto (177Lu-PSMA-617) Received the US FDA’s Approval as the First Targeted Radioligand Therapy for Progressive, PSMA Positive mCRPC

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Novartis’ Pluvicto (177Lu-PSMA-617) Received the US FDA’s Approval as the First Targeted Radioligand Therapy for Progressive, PSMA Positive mCRPC

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 

Click here to­ read the full press release 

Neha

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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