US FDA Approves New Treatment for B-Cell Acute Lymphoblastic Leukemia

The United States Food and Drug Administration has just approved a new drug for the treatment of adults who have relapsed or refractory B-cell precursor acute lymphoblastic leukemia. This drug is Besponsa (inotuzumab ozogamicin) and it has showed a rate of completion remission higher than in patients treated with chemotherapy, by a ratio of 81 percent to 29 percent. The drug also performed better in terms of rate of minimal residual disease negativity, which registered at 78 percent to 29 percent (with chemotherapy) among those patients who had achieved total remission.

According to FDA Oncology Center for Excellence, Richard Pazdur, MD, “For adult patients with B-cell ALL whose cancer has not responded to initial treatment or has returned after treatment, life expectancy is typically low.” Also the acting director of the Office of Hematology and Oncology Products with the FDA’s Center for Drug Evaluation and Research, Pazdur goes on to say, “These patients have few treatments available and today’s approval provides a new, targeted treatment option.”

Studies explain that this type of blood cancer is hard to treat and patients must achieve complete remission in order to be eligible for what is only a potential cure in a bone marrow transplant.”

Analyzing and testing of this drug involved only 218 patients. 36 percent of the patients who took Besponsa saw their cancer go inactive for eight months. 17 percent of those who had received chemotherapy saw only a total remission of five months, on average. Simple math, then, suggests that Besponsa has twice the success rate and with nearly twice the longevity.

As with any other drug, Besponsa does have some side effects. These can include: low platelet levels (thrombocytopenia), low white blood cell levels (neutropenia, leukopenia), low red blood cell levels (anemia), infection, fatigue, fever (pyrexia), severe bleeding (hemorrhage), nausea, headache, low white blood cell levels accompanied by fever (febrile neutropenia), abdominal pain, liver damage (transaminases and/or gamma-glutamyltransferase increased), and high levels of bilirubin in the blood (hyperbilirubinemia).

The treatment is important because this condition is among the more rapidly progressing types of cancer, characterized by the bone marrow making too many B-cell lymphocytes. According to the United States National Cancer Institute approximately 5,970 people in the United States will receive a diagnosis for ALL this year, alone, and of that population, approximately 1,440 will die because of the disease.

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