Inotuzumab ozogamicin Approved ADC

Antibody Information

Entry ID	50
INN	Inotuzumab ozogamicin
Status	Approved
Drug code(s)	CMC544, G5/44-calicheamicin
Brand name	Besponsa
mAb sequence source	mAb humanized
General Molecular Category	ADC
Format, general category	Full length Ab conjugate
Format details	None
Isotype (Fc)	IgG4
Light chain isotype	kappa
Linker	AcBut acyl hydrazone-disulfide, Cleavable linker
Ave. DAR	2 to 3 drugs per mAb
Conjugated/fused moiety	DNA binding, Calicheamicin
Discovery method/technology	None

Therapeutic information

Target(s)	CD22
Indications of clinical studies	non-Hodgkin Lymphoma, Acute Lymphoblastic Leukemia, Diffuse Large B-Cell Lymphoma
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
Status	Active
Start of clinical phase (IND filing or first Phase 1)	July 15, 2003
Start of Phase 2
Start of Phase 3	November 15, 2007
Date BLA/NDA submitted to FDA	December 20, 2016
Year of first approval (global)	2017
Date of first US approval	August 17, 2017
INN, US product name	Inotuzumab ozogamicin
US or EU approved indications	US: First approval for Acute lymphoblastic leukemia (BESPONSA is indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)). US supplemental approval for Acute lymphoblastic leukemia (BESPONSA is indicated for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients 1 year and older.) (as of March 6, 2024 label). EU: First approval for Acute lymphoblastic leukemia (BESPONSA is indicated as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL). Adult patients with Philadelphia chromosome positive (Ph+) relapsed or refractory B cell precursor ALL should have failed treatment with at least 1 tyrosine kinase inhibitor (TKI)) (as per EPAR - Product Information last updated on February 14, 2024).

Company information

Company	Pfizer
Licensee/Partner	None
Comments about company or candidate	Approved in the EU June 29, 2017; approved in US on Aug 17, 2017 Orphan designation in EU. Breakthrough Therapy designation for ALL; as of April 2015, the mAb met the first goal of a Phase III trial by increasing the chances of complete remission among adult acute lymphoblastic leukemia patients. As of May 2013, Pfizer has discontinued Phase 3 randomized study of inotuzumab ozogamicin in relapsed or refractory aggressive non-hodgkin lymphoma (NHL) due to futility. The company will continue evaluating the compound in other hematologic malignancies such as adult acute lymphoblastic leukemia (ALL)
Full address of company	66 Hudson Boulevard East, New York, NY 10001-2192 USA North America United States of America https://www.pfizer.com/contact

Description/comment

S228P hinge mutation. acid-labile 4-(4′-acetylphenoxy) butanoic acid (acetyl butyrate) linker

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None