Good news in the medicine field, because FDA officially approved a targeted new drug to treat adults with ALL (Acute lymphoblastic leukemia). The Inotuzumab ozogamicin is used in treating the rapidly progressing type of cancer where the bone marrow makes too many B-cell lymphocytes. Besponsa is responsible for binding B-cell ALL cancerous cells and expressing CD22 antigen, which blocks the growth of this kind of cells.
Richard Pazdur, MD, is the director of FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research highlighted the importance of this kind of treatment by saying that the patients have quite limited treatment alternatives available and that the approval provides new perspectives for the people with this type of condition. Pazdur also stated a sad truth when it comes to this area; for adult patients with b-cell ALL whose cancer did not respond to the treatment or returned after it, life expectancy is mostly low.
The efficacy and safety of Besponsa were studied in a trial with 326 patients with refractory or relapsed B-cell ALL, who had received prior treatments. Of the 218 patients who were evaluated, 35.8% who received Besponsa treatment had a complete remission over a period of 8 months.
On the other hand, there are some warnings for Besponsa including severe liver damage, blockage of veins in the liver or sinusoidal obstruction that were experienced by a few patients who took Besponsa. Moreover, the warning also includes a great risk of death for those who used Besponsa after receiving a specific type of stem cell transplant.
The list of the side effects does not end here; other serious consequences on the individual’s health condition can include a decrease in blood cell and platelet production, problems with the heart’s electrical pulses and infusion-related reactions.