Bayer has announced that the Chinese National Medical Products Administration (NMPA) approved Xofigo (radium-223 dichloride) for treating patients with castration-resistant prostate cancer (CRPC).
The drug has been approved based on the Phase 3 ALSYMPCA trial and Phase III 15397 trial.
The ALSYMPCA trial was a double-blind, placebo-controlled trial. The drug was compared with the placebo plus standard of care combination; overall survival was considered as the primary endpoint. At the interim analysis, Xofigo showed significant improvement in the overall survival (median survival was 14.0 months in Xofigo arm versus 11.2 months in placebo + SoC arm). The risk of death in the Xofigo arm was reduced by 30% compared to the placebo arm.
Further, the adverse events reported in the Xofigo arm were consistently compared to the placebo arm.
Xofigo is a targeted alpha therapy, which targets bone, targeting specifically bone metastases by forming a complex with hydroxyapatite. The drug is administered as an intravenous injection.
The product has been approved in the U.S., Europe, Japan, and the other 50 countries.
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