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The U.S. Food and Drug Administration (FDA) announced Wednesday that Pfizer (NYSE:PFE) has received U.S. regulatory approval for its antibody-drug conjugate inotuzumab ozogamicin, marketed as Besponsa for an additional indication in children with a form of leukemia.
In 2017, the agency cleared the CD22-targeting ADC for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL), the most common type of ALL.
The latest decision allows its use in children aged one year and older with CD-22 positive R/R B-cell precursor ALL.
The approval was based on data suggesting that Besponsa led to 42% of complete remission (CR) with a median of 8.2 months of CR duration in a 52-patient open-label study.
The news highlights the New York-based pharma giant’s ongoing efforts in the ADC space. The company acquired ADC drug developer Seagen in December following a $43B deal.