Besponsa (inotuzumab ozogamicin) approved for adults with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or recurrent.
B-cell precursor ALL, if not treated is probably fatal within a few months.
Besponsa is an antibody-drug conjugate, a monoclonal antibody linked to a chemotherapy drug: calicheamin.
Attaches to B-cell ALL cancer cells that express the CD22 protein, blocking the growth of cancer cells.
It acts through a T cell independent mechanism.
CD22 directed antibody drug conjugate.
It is intended to target and kill only the cancer cells and spare healthy cells.
Of patients evaluated in the INO-VATE trial, 35.8% who received the drug had a complete remission for an average of 8 months and 17.4% who received standard treatment had a complete remission for an average of 4.9 months.
Inotuzumab ozogamicin Is an anti-CD 22 antibody conjugated to calicheamicin, what results in higher response rates versus chemotherapy (about 80% versus about 30%): associated with an MRD negative remission of 78% versus 28% for chemotherapy in patients with relapsed ALL.
In the combination of inotuzumab with a modified hyper – CVAD leads to a three-year progression free survival and overall survival of 50% in patients 60 years or older with ALL.
Given as an intravenous infusion.
Common side effects include: low blood counts, fatigue, severe bleeding, fever, nausea, headache, abdominal pain, abnormal liver tests, and high levels of bilirubin in the blood.
It has a myelosuppressive properties and a low incidence of venoocclusive disease and other forms of hepatic injury.
Serious side effects include increased risk of severe liver damage in patients who receive this drug after certain kinds of stem cell transplant, infusion-related reactions, and heart problems.
Hepatotoxicity is the primary adverse event and can occur either before after hematopoietic stem cell transplant.
Its primary toxicity his hepatic sinusoidal obstruction syndrome.
It may cause harm to a developing fetus or a newborn baby.