06 Mar 2024: Pfizer’s ADC inotuzumab ozogamicin gained FDA approval for use in pediatric patients with acute lymphoblastic leukemia
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 53 pediatric patient open-label study
In 2017, the FDA approved the CD22-targeting ADC for adults with relapsed or refractory ALL. Now, it’s also approved for children aged one year and older with CD-22 positive R/R B-cell precursor ALL
The news highlights Pfizer’s ongoing efforts in the ADC space. The company acquired ADC drug developer Seagen in December following a $43B deal