USFDA has given a green signal to pharma major Pfizer Inc’s manufactured antibody-drug conjugate (ADC), Besponsa or inotuzumab ozogamicin, used for the treatment of relapsed or refractory B-cell precursor Acute lymphoblastic leukemia (ALL) and other blood cancers in the adults.
“Besponsa will help address a significant need for new treatment options in B-cell acute lymphoblastic leukemia, and may help more patients reach stem cell transplant, which provides the best chance for long-term remission,” Liz Barrett, global president, Pfizer Oncology, said.
Acute lymphoblastic leukemia (ALL) is a cancer that affects the immune system. This life saving drug, Besponsa, is composed of a monoclonal antibody (mAb) targeting CD22, a cell surface antigen expressed on cancer cells in almost all B-ALL patients —linked to a cytotoxic agent.
According to Pfizer, when Besponsa binds to the CD22 antigen on B-cells, it is internalized into the cell, where the cytotoxic agent calicheamicin is released causing cell death. It is administered as a one-hour intravenous infusion that can be given in the outpatient setting of care for appropriate patients.
“The approval of Besponsa is an important step forward for adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia, a rare disease that can be fatal within a matter of months if left untreated,” Barrett said.