PARAMETER

DATA

Manufacturer

Amgen, Inc.

Indication

Xgeva is a RANK ligand (RANKL) inhibitor indicated for:

• Prevention of skeletal-related events in patients with bone metastases from solid tumors.
• Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is un-resectable or where surgical resection is likely to result in severe morbidity

Cell Substrate

Chinese hamster ovary (CHO) cells

Manufacturing platform

Denosumab is manufactured by a batch-wise cell culture process in the production bioreactor followed by a harvest process using conventional unit operations (centrifugation and membrane filtration), and a purification process employing several chromatography steps (protein A, cation exchange and hydrophobic interaction), a viral inactivation step and a viral removal step. Finally, formulation is made by means of ultrafiltration/diafiltration.

Dose in vial/final container

120 mg/1.7 mL (70 mg/mL) single-use vial

Dose to patient

• Bone Metastasis from Solid Tumors: Administer 120 mg every 4 weeks as a subcutaneous injection in the upper arm, upper thigh, or abdomen.
• Giant Cell Tumor of Bone: Administer 120 mg every 4 weeks with additional 120 mg doses on Days 8 and 15 of the first month of therapy.

NCT

TRIAL PHASE

NO OF PATIENTS ENROLLED

TITLE

COUNTRIES

Primary Phase 3 trials Reviewed in original BLA

NCT00089791

3

7808

A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis  

-

NCT00091793

3

332

Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis  

-

NCT00089661

3

252

AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer       

-

NCT00089674

3

1468

AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer

-

Key trials with the new data in CR safety update

NCT00523341

3

4550

Extension Study to Evaluate the Long-Term Safety and Efficacy of Denosumab in the Treatment of Osteoporosis

-

NCT00325468

3

200

An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women with Low Bone Mineral Density

-

NCT00518531

3

250

Denosumab Adherence Preference Satisfaction Study

-

NCT00887965

2

15

A Transiliac Crest Bone Histology and Histomorphometry Study in Postmenopausal Women with Low Bone Mass or Osteoporosis Previously Treated with Denosumab

-