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FDA Approved Besponsa for Children With Acute Lymphoblastic Leukemia
A nationally-published, award-winning journalist, Alex Biese joined the CURE team as an assistant managing editor in April 2023. Prior to that, Alex's work was published in outlets including the Chicago Sun-Times, MTV.com, USA TODAY and the Press of Atlantic City. Alex is a member of NLGJA: The Association of LGBTQ+ Journalists, and also performs at the Jersey Shore with the acoustic jam band Somewhat Relative.
Brielle Benyon, Assistant Managing Editor for CURE®, has been with MJH Life Sciences since 2016. She has served as an editor on both CURE and its sister publication, Oncology Nursing News. Brielle is a graduate from The College of New Jersey. Outside of work, she enjoys spending time with family and friends, CrossFit and wishing she had the grace and confidence of her toddler-aged daughter.
The Food and Drug Administration approved Besponsa for pediatric patients aged 1 and older with relapsed or refractory CD22-positive, B-cell precursor ALL.
The Food and Drug Administration (FDA) has approved Besponsa (inotuzumab ozogamicin) for pediatric patients 1 year and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL), the agency has announced.
The efficacy of Besponsa was determined in a multicenter, single-arm, open-label study with 53 pediatric patients 1 year old and older with relapsed or refractory CD22-positive B-cell precursor ALL, according to the agency, which noted that the study evaluated two dose levels: an initial dose of 1.4 mg/m2/cycle in 12 patients and 1.8 mg/m2/cycle in 41 patients, with premedications including methylprednisolone 1 mg/kg (maximum of 50 mg), an antipyretic and an antihistamine, and patients receiving a median of 2 cycles of therapy.
Twenty-two of the 53 patents, or 42%, achieved complete response, indicating that their disease completely disappeared, with a median duration of complete response being 8.2 months.
Additionally, minimal residual disease (MRD)-negative complete response, defined as 5% or less blasts found in the bone marrow and no cancer found in the peripheral blood, occurred in 21 of 22 patients (95.5%) who had a complete response, based on flow cytometry, and 19 of 22 (86.4%) based on RQ-PCR, which is a test of the blood and bone marrow.
Besponsa was initially approved by the FDA in 2017 for the treatment of adults with relapsed or refractory ALL. According to the drug’s website, Besponsa is an antibody drug conjugate that works by targeting and binding to CD22, which is a protein found on many B-cell ALL cells. It then is internalized by the cancer cell and releases the cancer-killing component.
The most common side effects from Besponsa that occurred in 20% or more of patients were thrombocytopenia, fever, anemia, vomiting, infection, hemorrhage, neutropenia, nausea, leukopenia, febrile neutropenia, increased transaminases, abdominal pain and headache.
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