Regulators in Europe have given the green light to Bayer and Algeta’s prostate cancer therapy Xofigo.
The marketing authorisation for Xofigo (radium Ra 223 dichloride) granted by the European Commission was expected given that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on the drug in September. The alpha-pharmaceutical, which works by binding with minerals in the bone to deliver radiation directly to bone tumours, was approved by the US Food and Drug Administration in May.
The latest approval is based on a Phase III trial which was stopped early following data which showed that Xofigo significantly improved overall survival – 14.0 months versus 11.2 months for placebo. Christopher Parker of the Royal Marsden in London, and lead investigator on the trial, noted that the drug targets bone metastases, “delivering a localised effect to offer patients prolonged survival [and] making it an exciting advance in the treatment of this cancer.”
The European approval is another boost to the German group’s growing oncology franchise, said Kemal Malik, head of global development at Bayer HealthCare. The drug has got off to a decent start in the USA, where the latter and Algeta co-promote; third-quarter sales reached $17 million.
