Date: 2012-04-26
Type of information: Refusal of a Market Authorisation in the US
Product name: Xgeva®
Compound: denosumab
Therapeutic area: Cancer - Oncology
Action mechanism:
- monoclonal antibody. Xgeva® is a fully human monoclonal antibody that binds to RANK Ligand, a protein essential for the formation, function and survival of osteoclasts (the cells that break down bone). Xgeva® prevents RANK Ligand from activating its receptor, RANK, on the surface of osteoclasts, thereby decreasing bone destruction.
Company: Amgen (USA)
Disease: reduction of the risk of developing bone metastases in men with castrate-resistant prostate cancer (extension of indication)
Latest news:
- • On April 26, 2012, Amgen announced that the FDA has issued a Complete Response Letter for the supplemental Biologics License Application (sBLA) for Xgeva® (denosumab) to treat men with castration-resistant prostate cancer (CRPC) at high risk of developing bone metastases. The Complete Response Letter states that FDA cannot approve the application in its present form. The FDA determined that the effect on bone metastases-free survival (BMFS) was of insufficient magnitude to outweigh the risks (including osteonecrosis of the jaw) of Xgeva® in the intended population, and requested data from an adequate and well-controlled trial(s) demonstrating a favorable risk-benefit profile forXgeva® that is generalizable to the U.S. population.
• On June 27, 2011, Amgen announced the submission of a supplemental Biologics License Application (sBLA) to the FDA to expand the indication for Xgeva® (denosumab) to treat men with castrate-resistant prostate cancer to reduction of the risk of developing bone metastases in men with castrate-resistant prostate cancer. The sBLA submission is based on a pivotal Phase 3 Study ('147) evaluating Xgeva® versus placebo in 1,432 men with castrate-resistant prostate cancer. Results of the '147 study demonstrate that Xgeva® significantly prolonged bone metastasis-free survival by more than four months compared with placebo (29.5 versus 25.2 months, respectively) in men with castrate-resistant prostate cancer that had not yet spread to the bone. Bone metastasis-free survival is a composite measure of the development of bone metastases or death.
Patents:
Submission of marketing authorization application USA : 2011-07-26
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
