Bayer cancer drug gets EU approval
pharmafile | November 18, 2013 | News story | Sales and Marketing | Bayer, CHMP, EU, Xtandi, Zytiga, xofigo
Bayer’s prostate cancer treatment Xofigo has been shown the green light by the European Commission.
Xofigo (radium Ra 223 dichloride) is approved for castration-resistant prostate cancer which has spread to bone tissue. It is already licensed in the US for the same indication.
Research firm DrugAnalyst predicts the drug will bring in global revenues of $488 million by 2020, but is wary that it has already been surpassed by other treatments.
An evaluation by the company said: “The drug improved survival by 3.6 months, but since then we’ve seen both J&J’s Zytiga and Astellas & Medivation’s Xtandi approved both showing c.5-month survival benefits – hasn’t the drug already been superseded?”
This year Zytiga (abiraterone acetate) and Xtandi (enzalutamide) enjoyed Q3 sales of $198.5 million and $108.5 million, respectively. Bayer’s pill brought in just $17 million over the same period – although it was newly-approved at the time and its sales were limited to the US.
The intravenous treatment works by specifically targeting cancerous bone tissue. It attacks tumour cells with short-range alpha radiation, which serves to minimise damage to healthy cells.
The authorisation is based on a prematurely halted Phase III trial which showed the drug significantly extended overall survival compared to placebo.
Lead researcher Christopher Parker said: “Bone metastases occur in the majority of men living with castration-resistant prostate cancer and can result in pain and even death.”
He continued: “Xofigo targets bone metastases, delivering a localised cytotoxic effect to offer patients prolonged survival, making it an exciting advance in the treatment of this cancer.”
Xofigo’s EU authorisation follows the drug’s positive recommendation by the European Committee for Medicinal Products for Human Use in September.
Bayer acquired the rights to the treatment in a 2009 deal with Norwegian oncology specialist Algeta worth $800 million. The latter now co-promotes Xofigo in the US with Bayer.
Around 910,000 cases of prostate cancer were recorded in 2008, with some of the highest incidence rates in west and north Europe, according to the World Cancer Research Fund. Global incidence is expected to nearly double by 2030.
Hugh McCafferty
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