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Novartis’ Pluvicto Receives EC's Approval for Progressive PSMA+ Metastatic Castration Resistant Prostate Cancer

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Novartis’ Pluvicto Receives EC's Approval for Progressive PSMA+ Metastatic Castration Resistant Prostate Cancer

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  • The approval was based on the P-III study (VISION) results evaluating the efficacy and safety of Pluvicto (7.4 GBq, IV, q6w for a maximum of 6 cycles) + BSoC vs BSoC in a ratio (2:1) in 831 patients with PSMA PET-scan positive mCRPC who have received AR pathway inhibition and taxane-based CT
  • The result showed a 38% reduction in risk of death, a 60% reduction in risk of rPFS, ORR (30% vs 2%) in patients with evaluable disease at baseline
  • In Oct 2022, the CHMP issued a positive opinion and is applicable to all 27 EU member states, Iceland, Norway, Northern Ireland & Liechtenstein. Pluvicto is also approved in the US and other countries incl. Great Britain and Canada for the same indication

Ref: Novartis | Image: Novartis 

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

Click here to­ read the full press release 

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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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