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Introduction <p>Ponatinib is a third-generation BCR::ABL1 tyrosine kinase inhibitor indicated for the treatment of chronic myeloid leukemia and Philadelphia chromosome–positive acute lymphoblastic leukemia. Following its initial commercial availability in the USA on 14 December 2012, safety concerns, notably vascular occlusive events, led to the implementation of post-approval risk-management measures (RMMs).</p> Objective <p>This retrospective study assessed the impact of these measures on adverse event (AE) reporting rates for ponatinib’s important identified risks (IIRs).</p> Methods <p>AEs related to ponatinib’s IIRs were identified from the Incyte Global Safety Database for the period 14 December 2012 to 13 December 2022, using a Medical Dictionary for Regulatory Activities–based search of postmarketing reports. Reporting rates were calculated as the ratio of reported AEs to estimated postmarketing exposure.</p> Results <p>During the first year of commercialization, the most frequently reported AEs for ponatinib pertained to the IIRs of myelosuppression, skin reactions, infections, and arterial occlusive events, with reporting rates of 0.505, 0.362, 0.330, and 0.291, respectively. Following implementation of post-approval RMMs in December 2013, reporting rates of these IIRs decreased considerably during the first 2 years of commercialization. By the end of year 10, reporting rates of these IIRs further decreased to 0.043, 0.030, 0.045, and 0.038, respectively. Notably, reporting rates for each IIR across the 10-year period were considerably lower than the reporting rates observed during the first year of ponatinib commercialization.</p> Conclusion <p>This study shows declining AE reporting rates for ponatinib’s IIRs since it first became commercially available, potentially because of the implementation of RMMs and increased clinicians’ awareness.</p>

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Ponatinib Safety Profile: An Analysis of 10 Years of Real-World Experience

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月18日

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  • Elias Jabbour,
  • Fausto Castagnetti,
  • Mouna Bardey-Kanaan,
  • Romuald Soichez,
  • Nhan Thanh Nguyen,
  • Deborah Kelly,
  • Federica Rizzo,
  • Petros Patos,
  • Valentín García-Gutiérrez

摘要

Introduction

Ponatinib is a third-generation BCR::ABL1 tyrosine kinase inhibitor indicated for the treatment of chronic myeloid leukemia and Philadelphia chromosome–positive acute lymphoblastic leukemia. Following its initial commercial availability in the USA on 14 December 2012, safety concerns, notably vascular occlusive events, led to the implementation of post-approval risk-management measures (RMMs).

Objective

This retrospective study assessed the impact of these measures on adverse event (AE) reporting rates for ponatinib’s important identified risks (IIRs).

Methods

AEs related to ponatinib’s IIRs were identified from the Incyte Global Safety Database for the period 14 December 2012 to 13 December 2022, using a Medical Dictionary for Regulatory Activities–based search of postmarketing reports. Reporting rates were calculated as the ratio of reported AEs to estimated postmarketing exposure.

Results

During the first year of commercialization, the most frequently reported AEs for ponatinib pertained to the IIRs of myelosuppression, skin reactions, infections, and arterial occlusive events, with reporting rates of 0.505, 0.362, 0.330, and 0.291, respectively. Following implementation of post-approval RMMs in December 2013, reporting rates of these IIRs decreased considerably during the first 2 years of commercialization. By the end of year 10, reporting rates of these IIRs further decreased to 0.043, 0.030, 0.045, and 0.038, respectively. Notably, reporting rates for each IIR across the 10-year period were considerably lower than the reporting rates observed during the first year of ponatinib commercialization.

Conclusion

This study shows declining AE reporting rates for ponatinib’s IIRs since it first became commercially available, potentially because of the implementation of RMMs and increased clinicians’ awareness.