inotuzumab ozogamicin

FDA Drug Profile — Besponsa

Drug Details

Generic Name
inotuzumab ozogamicin
Brand Names
Besponsa
Application Number
BLA761040
Sponsor
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
NDC Codes
1
Dosage Forms
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients
INOTUZUMAB OZOGAMICIN

Indications and Usage

1. INDICATIONS AND USAGE 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 . BESPONSA is a CD22-directed antibody and cytotoxic drug conjugate 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. ( 1 )