RANK-ligand inhibitor will have an additional year of data and market exclusivity in the EU.
The European Commission approved Amgen’s Xgeva® (denosumab) monoclonal antibody for the prevention of skeletal-related events (SREs) in adults with bone metastases from solid tumors. Approval applies to all 27 EU member states, and also provides for an additional year of data and market exclusivity in EU countries, both because the indication was considered new for denosumab and on the basis of the clinical benefit of the drug in comparison with existing therapies, Amgen notes. Xgeva is already approved in the U.S. and Canada for preventing SREs in patients with bone metastases from solid tumors.
In June the firm submitted a sBLA to FDA requesting clearance to market the Xgeva for reducing the risk of bone metastases in men with castrate-resistant prostate cancer. Amgen says if this application is approved, Xgeva would be the first therapy licensed to prevent or delay the spread of cancer to the bone.
European approval for preventing bone metastases-related SREs was based on data from three Phase III head-to-head trials comparing Amgen’s RANK ligand inhibitor with zoledronic acid in delaying SREs. Over 5,700 patients with multiple tumor types were included. In patients with breast or prostate cancer and bone metastases, Xgeva was superior to zoledronic acid in reducing the risk of SREs. For patients with bone metastases due to other solid tumors or multiple myeloma, Xgeva was not inferior to zoledronic acid.
The combined trial data showed that in comparison with zoledronic acid, therapy using Xgeva delayed the time to first on-study SRE by 17%, or 8.2 months. Median time to first SRE was 27.6 months for Xgeva-treated patients, and 19.4 months for those treated using zoledronic acid.
Regulatory reviews for use of Xgeva in preventing SREs are currently in progress in various other countries including Japan, where the drug has been developed in collaboration with Daiichi-Sankyo. Amgen has separately partnered with GlaxoSmithKline for commercializing Xgeva in territories where Amgen doesn’t have a commercial presence. In these countries GSK will file relevant marketing applications.
Denosumab was approved (tradenamed Prolia™) in 2010 in the U.S., EU, Switzerland, Canada, and Australia for the treatment of postmenopausal women with osteoporosis at high risk for fracture. Phase III trials are in addition testing the antibody as a treatment for male osteoporosis. Amgen says the overall denosumab development program covers indications spanning osteoporosis, treatment-induced bone loss, rheumatoid arthritis, and numerous tumor types across the spectrum of cancer-related bone diseases.
