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