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<p>Core-binding factor acute myeloid leukemia (CBF-AML) is traditionally classified as a favorable-risk subtype; however, outcomes in the Indian context have not mirrored this biological advantage. Relapse rates approaching 40% in both pediatric and adult patients underscore a critical gap between expected and observed survival, largely attributable to reliance on conventional chemotherapy without gemtuzumab ozogamicin (GO). Emerging Indian data have identified measurable residual disease (MRD) positivity, KIT mutations, and a high co-mutation burden as key predictors of treatment failure with standard 3 + 7 induction and high-dose cytarabine consolidation alone. International randomized trials and meta-analyses consistently demonstrate that the addition of GO significantly reduces relapse risk and improves survival in favorable-risk AML, including CBF-AML, without unacceptable toxicity. Despite this unequivocal evidence, GO remains underutilized in India. This review examines the biological rationale, global clinical evidence, and India-specific barriers to GO implementation, while highlighting pragmatic strategies to bridge this gap. These include engagement with pharmaceutical stakeholders for sustainable pricing, incorporation of GO into government-funded oncology programs, and generation of indigenous clinical and real-world data. Given the young age and high curability of CBF-AML patients, the routine integration of GO into frontline therapy represents an urgent and ethically compelling opportunity to improve cure rates in India.</p>

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Revisiting the Role of Gemtuzumab Ozogamicin in Core-Binding Factor Acute Myeloid Leukemia: An Urgent Priority for India

  • 期刊论文

  • 发表日期：

    2026年4月8日

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  • Rahul Bhargava,
  • Shrinidhi Nathany,
  • Jayastu Senapati,
  • Tulika Seth,
  • Anusha Swaminathan,
  • Devyani Surange,
  • Nikhil M. Kumar,
  • J. Sherook,
  • Vikas Dua

摘要

Core-binding factor acute myeloid leukemia (CBF-AML) is traditionally classified as a favorable-risk subtype; however, outcomes in the Indian context have not mirrored this biological advantage. Relapse rates approaching 40% in both pediatric and adult patients underscore a critical gap between expected and observed survival, largely attributable to reliance on conventional chemotherapy without gemtuzumab ozogamicin (GO). Emerging Indian data have identified measurable residual disease (MRD) positivity, KIT mutations, and a high co-mutation burden as key predictors of treatment failure with standard 3 + 7 induction and high-dose cytarabine consolidation alone. International randomized trials and meta-analyses consistently demonstrate that the addition of GO significantly reduces relapse risk and improves survival in favorable-risk AML, including CBF-AML, without unacceptable toxicity. Despite this unequivocal evidence, GO remains underutilized in India. This review examines the biological rationale, global clinical evidence, and India-specific barriers to GO implementation, while highlighting pragmatic strategies to bridge this gap. These include engagement with pharmaceutical stakeholders for sustainable pricing, incorporation of GO into government-funded oncology programs, and generation of indigenous clinical and real-world data. Given the young age and high curability of CBF-AML patients, the routine integration of GO into frontline therapy represents an urgent and ethically compelling opportunity to improve cure rates in India.