FDA approves expanded use of Besponsa

The US Food and Drug Administration (FDA) late yesterday approved Pfizer’s (NYSE: PFE) antibody drug conjugate Besponsa (inotuzumab ozogamicin) to include patients one year of age and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (B-ALL).

The regulatory action expands on the initial approval of Besponsa that was granted to the US pharma giant in August 2017, which was for the treatment of adults with relapsed or refractory B-cell precursor ALL.

Efficacy was evaluated in a multicenter, single-arm, open-label study in 53 pediatric patients 1 year and older with relapsed or refractory CD22-positive B-cell precursor ALL. Two dose levels were evaluated - an initial dose of 1.4mg/m2/cycle in 12 patients and 1.8mg/m2/cycle in 41 patients. Pre-medications included methylprednisolone 1mg/kg (maximum of 50mg), an antipyretic, and an antihistamine. Patients received a median of 2 cycles of therapy (range: 1 to 4 cycles).