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FDA approves Bosutinib for pediatric Chronic Myelogenous Leukemia patients - Video

Published On 2023-09-29T10:15:19+05:30  |  Updated On 30 Jan 2024 5:23 PM IST
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Overview

On September 26, 2023, the Food and Drug Administration (FDA) granted approval for the use of bosutinib in pediatric patients aged 1 year and older who have chronic phase (CP) Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML). This approval covers cases that are newly diagnosed or those that are resistant or intolerant to prior therapy. Additionally, the FDA approved a new capsule dosage form, available in 50 mg and 100 mg strengths.

The approval followed an assessment of the drug's efficacy in the BCHILD trial (NCT04258943), an open-label, multicenter study. The trial aimed to determine the recommended dose of bosutinib in pediatric patients with newly diagnosed and resistant or intolerant CP Ph+ CML. It also evaluated the drug's safety, tolerability, and pharmacokinetics in this patient population. In total, 28 patients with resistant or intolerant CP Ph+ CML and 21 patients with newly diagnosed CP Ph+ CML participated in the trial.

For pediatric patients with resistant or intolerant CP Ph+ CML, the major cytogenetic response and complete cytogenetic response rates were 82.1% and 78.6%, respectively, with an MMR rate of 50%. Among the 14 patients who achieved major molecular response MMR, two lost MMR after 13.6 and 24.7 months on treatment. The median follow-up was 23.2 months.

The most common adverse reactions in pediatric patients (≥20%) included diarrhea, abdominal pain, vomiting, nausea, rash, fatigue, hepatic dysfunction, headache, pyrexia, decreased appetite, and constipation. The most common laboratory abnormalities that worsened from baseline (≥45%) were increased creatinine, increased alanine aminotransferase or aspartate aminotransferase, decreased white blood cell count, and decreased platelet count.

The recommended dosage for pediatric patients with newly diagnosed CP Ph+ CML is 300 mg/m2 orally once daily with food, while the recommended dose for those with resistant or intolerant CP Ph+ CML is 400 mg/m2 orally once daily with food. For patients who cannot swallow capsules, the capsule contents can be mixed with applesauce or yogurt.

Speakers

Isra Zaman

B.Sc Life Sciences, M.Sc Biotechnology, B.Ed

Isra Zaman is a Life Science graduate from Daulat Ram College, Delhi University, and a postgraduate in Biotechnology from Amity University. She has a flair for writing, and her roles at Medicaldialogues include that of a Sr. content writer and a medical correspondent. Her news pieces cover recent discoveries and updates from the health and medicine sector. She can be reached at editorial@medicaldialogues.in.

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751
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