Updated safety of midostaurin plus chemotherapy in newly diagnosed FLT3 mutation–positive acute myeloid leukemia: the RADIUS-X expanded access program

Gail J. Roboz, Stephen A. Strickland, Mark R. Litzow, Andrew Dalovisio, Alexander E. Perl, Gaetano Bonifacio, Kelly Haines, Alysha Barbera, Das Purkayastha, Kendra Sweet

Research output: Contribution to journalArticle

Abstract

Approval of midostaurin, a multikinase inhibitor, in combination with chemotherapy for the treatment of adults with newly diagnosed FLT3 mutation–positive acute myeloid leukemia, was based on the phase 3 RATIFY trial results. RADIUS-X (NCT02624570) was an expanded access program providing access to midostaurin during regulatory review and extending the understanding of the safety and tolerability of midostaurin. Patients aged ≥18 years received midostaurin with 1–2 cycles of induction therapy (cytarabine plus daunorubicin or idarubicin) and ≤4 cycles of high-dose cytarabine consolidation chemotherapy or as single-agent maintenance therapy. The study enrolled 103 patients. No new safety events were observed; toxicities were not influenced by age, anthracycline choice, or coadministration of CYP3A4 inhibitors. The most common adverse events (AEs) were febrile neutropenia, nausea, and diarrhea. During maintenance, 46% of patients reported AEs. Midostaurin demonstrated a manageable safety profile and was associated with high transplant and low on-treatment relapse rates.

Original languageEnglish (US)
JournalLeukemia and Lymphoma
DOIs
StateAccepted/In press - 2020

Keywords

  • Acute myeloid leukemia
  • FLT3
  • idarubicin
  • maintenance
  • midostaurin

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

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