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Date: 2018-01-05

Type of information: Granting of a Market Authorisation in the US

Product name: Xgeva®

Compound: denosumab

Therapeutic area: Cancer - Oncology - Rare diseases

Action mechanism:

  • monoclonal antibody. Denosumab 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 - CA)

Disease: prevention of skeletal-related event (SRE) in patients with multiple myeloma

Latest news:

  • • On January 5, 2018, Amgen announced that the FDA has approved the supplemental Biologics License Application (sBLA) for Xgeva® (denosumab) to expand the currently approved indication for the prevention of skeletal-related events in patients with bone metastases from solid tumors to include patients with multiple myeloma. The approval is based on data from the pivotal Phase 3 '482 study, the largest international multiple myeloma clinical trial ever conducted, which enrolled 1,718 patients.
  • The '482 study met the primary endpoint, demonstrating non-inferiority of Xgeva® to zoledronic acid in delaying the time to first on-study skeletal-related event in patients with multiple myeloma (HR=0.98, 95 percent CI: 0.85, 1.14; p=0.01). The secondary endpoints, delaying time to first skeletal-related event and delaying time to first-and-subsequent skeletal-related events, did not demonstrate superiority. Overall survival was comparable between Xgeva® and zoledronic acid, with a hazard ratio of 0.90 (95 percent CI: 0.70, 1.16; p=0.41). The median difference in progression-free survival favored Xgeva® by 10.7 months (HR=0.82, 95 percent CI: 0.68-0.99; descriptive p=0.036). Median progression-free survival was 46.1 months (95 percent CI: 34.3 months, not estimable [NE], n=219) for Xgeva® and 35.4 months (95 percent CI: 30.2 months, NE, n=260) for zoledronic acid.

Patents:

Submission of marketing authorization application USA :

Submission of marketing authorization application UE:

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization: 2018-01-05

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