Bayer has won another major EU approval in oncology after the European Commission back Xofigo for use in prostate cancer.
The marketing authorisation covers the use of an injectable version of the company’s radiotherapy Xofigo (radium Ra 223 dichloride) for the treatment of men with castration-resistant prostate cancer (CRPC) who also have symptomatic bone metastases and no known visceral metastases.
The decision comes just over two months after Bayer received approval for fellow oncology drug Stivarga (regorafenib) for use in the treatment of colorectal cancer.
Both drugs are also available in the US and are emerging as key products in Bayer’s strong portfolio of recent launches, with the company noting at the start of the year their potential blockbuster status.
The Xofigo approval is based on data from the phase III ALSYMPCA trial, which demonstrated that the drug was able to improve median overall survival in men with CRPC compared to placebo.
The study’s principal investigator Dr Christopher Parker explained the action of Xofigo.
“Bone metastases occur in the majority of men living with castration-resistant prostate cancer and can result in pain and even death,” said Dr Parker.
He added: “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.”
Bayer acquired Xofigo from Norwegian company Algeta in 2009. The deal granted full commercialisation rights in Europe to Bayer while in the US Bayer co-promotes the drug with Algeta.
Xofigo is one of several new treatment options approved in the past few years for men with CRPC.
Sanofi’s Jevtana (cabazitaxel) and Janssen’s Zytiga (abiraterone acetate) are already key products for their respective firms, while Astellas recently won approval for Xtandi (enzalutamide).
There have been disappointments, however, including trail failures for AstraZeneca’s zibotentan and Bristol-Myers Squibb’s Yervoy (ipilimumab).