Daratumumab Approved Naked monospecific

Antibody Information

Entry ID	YABS0067
INN	Daratumumab
Status	Approved
Drug code(s)	HUMAX-CD38
Brand name	Humax-CD38
mAb sequence source	mAb human
General Molecular Category	Naked monospecific
Format, general category	Full length Ab
Format details	None
Isotype (Fc)	IgG1
Light chain isotype	kappa
Linker	None
Ave. DAR	None
Conjugated/fused moiety	None
Discovery method/technology	Transgenic mouse (GenPharm/Medarex/BMS transgenic mouse platform Ultimab)

Therapeutic information

Target(s)	CD38
Indications of clinical studies	Multiple Myeloma
Primary therapeutic area	Cancer

Development stage information

Phase lengths*

*The graph represents early-stage clinical development phase lengths. For molecules approved or under evaluation for marketing authorization in the US is provided a complete overview of all clinical development phase lengths. Phase lengths are calculated from the start of the first in human (FIH) study (Start of clinical phase). “Start of Phase 2” bar represents Phase 1 length (Start of clinical phase to start of Phase 2); “Start of Phase 3” bar represents Phase 1+2 length (Start of clinical phase to start of Phase 3); “Date BLA/NDA submitted” bar represents Phase 1+2+3 length (Start of clinical phase to Date BLA/NDA submitted); and “Date of first US approval” bar represents Phase 1 to first US approval length (Start of clinical phase to Date of first US approval).

Most advanced stage of development (global)	Approved EU, US, Japan, Australia, UK
Status	Active
Start of clinical phase (IND filing or first Phase 1)	November 15, 2007
Start of Phase 2
Start of Phase 3	June 15, 2014
Date BLA/NDA submitted to FDA	July 09, 2015
Year of first approval (global)	2015
Date of first US approval	November 16, 2015
INN, US product name	Daratumumab
US or EU approved indications	Multiple myeloma: 1) in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; 2) in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; 3) in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor; 4) as monotherapy, 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 doublerefractory to a PI and an immunomodulatory agent. First-line use to treat patients newly diagnosed with multiple myeloma who are not eligible to receive high-dose chemotherapy and autologous stem cell transplant.

Company information

Company	Genmab
Licensee/Partner	Janssen Research & Development
Comments about company or candidate	Accelerated approval in US to treat patients with multiple myeloma who have received at least three prior treatments. Rolling BLA initiated in early June 2015 for 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 (IMiD), or who are double refractory to a PI and an IMiD. Fast track designation in US for MM; Breakthrough Therapy Designation from FDA for MM. Priority review in US. Breakthrough therapy designation granted in Aug 2016 for use in combination with Revlimid, or lenalidomide, and dexamethasone, and Velcade, or bortezomib, and dexamethasone for the treatment of multiple myeloma patients who have received at least one previous therapy
Full address of company	Copenhagen, Denmark Europe Denmark https://www.genmab.com/

Description/comment

None

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None