PARAMETER

DATA

Manufacturer

Janssen Biotech, Inc.

Indication

DARZALEX is a human CD38-directed monoclonal antibody indicated for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.

Cell Substrate

Mammalian Chinese Hamster Ovary (CHO) cell line

Manufacturing platform

Daratumumab active substance is manufactured in an 11-stage process consisting of fed batch cell culture followed by purification with a series of chromatography, viral inactivation, and filtration steps. Formulation also takes place at the active substance level. The concentrated viral inactivation and neutralization (VIN) intermediate is obtained at Stage 5b. The CMC strategy for comparability included an evaluation of QC batch release results and additional biochemical, biophysical, and biological characterization data according to the guidance provided in ICH Q5E.

Dose in vial/final container

100 mg/5 mL solution in a single-dose vial

400 mg/20 mL solution in a single-dose vial

Dose to patient

16 mg/kg body weight:

• Weekly - Weeks 1 to 8
• Every two weeks - Weeks 9 to 24
• Every four weeks - Week 25 onwards until disease progression

NCT

TRIAL PHASE

NO OF PATIENTS ENROLLED

TITLE

COUNTRIES

Controlled Studies to support Efficacy and Safety

Uncontrolled Studies to support Efficacy and Safety

NCT01985126

2

124

An Efficacy and Safety Study of Daratumumab in Patients with Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy (Including a Proteasome Inhibitor [PI] and Immunomodulatory Drug [IMiD]) or Are Double Refractory to a PI and an IMiD

United States, Canada, Spain

NCT00574288

2

104

Daratumumab (HuMax®-CD38) Safety Study in Multiple Myeloma

United States, Denmark, Netherlands, Sweden

Studies to support Safety

NCT01615029

1, 2

45

Daratumumab in Combination with Lenalidomide and Dexamethasone in Relapsed and Relapsed-refractory Multiple Myeloma

United States, Denmark, France, Netherlands, United Kingdom

NCT01998971

1

240

A Study of JNJ-54767414 (HuMax CD38) (Anti-CD38 Monoclonal Antibody) in Combination with Backbone Treatments for the Treatment of Patients with Multiple Myeloma

United States, France, Spain

Other studies pertinent to the review of efficacy or safety (e.g. clinical pharmacological studies)

NCT02116569

1

9

A Study of Daratumumab in Japanese Participants with Relapsed or Refractory Multiple Myeloma

Japan