The European Commission has granted marketing approval for Bayer and Algeta’s Xofigo, six months after the drug was approved in the U.S. to treat castration-resistant prostate cancer (CRPC) that has spread to bones but not other organs.
In the EU, Xofigo (radium RA 223 dichloride) is approved for adults with castration-resistant prostate cancer and bone metastases but without visceral metastases.
The drug, with its alpha-particle-emitting radioactive therapeutic agent, binds with minerals in the bone to deliver radiation directly to bone tumors, limiting the damage to the surrounding normal tissues, according to FDA officials.
The approval is partially based on the Phase III ALSYMPCA trial, a randomized, double-blind, placebo-controlled international study of 921 men with symptomatic CRPC. Male patients receiving Xofigo lived a median of 14 months compared to 11.2 months for those on placebo.
Algeta President and CEO Andrew Kay said he the EU approval is expected to kick-start a royalty stream for the Norwegian drugmaker.
Under the pharma partners’ 2009 agreement, Algeta U.S. and Bayer will co-promote Xofigo in the U.S., while Bayer has licensed the full rights to the drug outside of the U.S. — Lena Freund
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