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References: Acute myeloid leukaemia (including APL)

134 sources cited on this page. Links open the primary source.

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  14. de Thé H, Lavau C, Marchio A, Chomienne C, Degos L, Dejean A. The PML-RAR alpha fusion mRNA generated by the t(15;17) translocation in acute promyelocytic leukemia encodes a functionally altered RAR. Cell. 1991;66(4):675-84. PubMedDOI
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  15. Kakizuka A, Miller WH Jr, Umesono K, Warrell RP Jr, Frankel SR, Murty VV, et al. Chromosomal translocation t(15;17) in human acute promyelocytic leukemia fuses RAR alpha with a novel putative transcription factor, PML. Cell. 1991;66(4):663-74. PubMedDOI
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  16. Warrell RP Jr, Frankel SR, Miller WH Jr, Scheinberg DA, Itri LM, Hittelman WN, et al. Differentiation therapy of acute promyelocytic leukemia with tretinoin (all-trans-retinoic acid). N Engl J Med. 1991;324(20):1385-93. PubMedDOI
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  17. Fenaux P, Le Deley MC, Castaigne S, Archimbaud E, Chomienne C, Link H, et al. Effect of all transretinoic acid in newly diagnosed acute promyelocytic leukemia. Results of a multicenter randomized trial. European APL 91 Group. Blood. 1993;82(11):3241-9. PubMed
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  18. Mayer RJ, Davis RB, Schiffer CA, Berg DT, Powell BL, Schulman P, et al. Intensive postremission chemotherapy in adults with acute myeloid leukemia. Cancer and Leukemia Group B. N Engl J Med. 1994;331(14):896-903. PubMedDOI
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  19. US Food and Drug Administration. openFDA Drugs@FDA record for NDA 020438 (Vesanoid, tretinoin capsules): original submission status date 22 November 1995 (record last updated 2026-10-16). Source
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  21. Shen ZX, Chen GQ, Ni JH, Li XS, Xiong SM, Qiu QY, et al. Use of arsenic trioxide (As2O3) in the treatment of acute promyelocytic leukemia (APL): II. Clinical efficacy and pharmacokinetics in relapsed patients. Blood. 1997;89(9):3354-60. PubMed
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  22. Tallman MS, Andersen JW, Schiffer CA, Appelbaum FR, Feusner JH, Ogden A, et al. All-trans-retinoic acid in acute promyelocytic leukemia. N Engl J Med. 1997;337(15):1021-8. PubMedDOI
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  23. Grimwade D, Walker H, Oliver F, Wheatley K, Harrison C, Harrison G, et al. The importance of diagnostic cytogenetics on outcome in AML: analysis of 1,612 patients entered into the MRC AML 10 trial. The Medical Research Council Adult and Children's Leukaemia Working Parties. Blood. 1998;92(7):2322-33. PubMed
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  24. Soignet SL, Maslak P, Wang ZG, Jhanwar S, Calleja E, Dardashti LJ, et al. Complete remission after treatment of acute promyelocytic leukemia with arsenic trioxide. N Engl J Med. 1998;339(19):1341-8. PubMedDOI
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  25. Sanz MA, Martín G, Rayón C, Esteve J, González M, Díaz-Mediavilla J, et al. A modified AIDA protocol with anthracycline-based consolidation results in high antileukemic efficacy and reduced toxicity in newly diagnosed PML/RARalpha-positive acute promyelocytic leukemia. PETHEMA group. Blood. 1999;94(9):3015-21. PubMed
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  26. US Food and Drug Administration. Trisenox (arsenic trioxide) injection: approved labeling accompanying NDA 21-248, September 2000. Source
  27. US Food and Drug Administration. Approval letter, NDA 21-248, Trisenox (arsenic trioxide) injection, dated 25 September 2000. Source
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  29. Sievers EL, Larson RA, Stadtmauer EA, Estey E, Löwenberg B, Dombret H, et al. Efficacy and safety of gemtuzumab ozogamicin in patients with CD33-positive acute myeloid leukemia in first relapse. J Clin Oncol. 2001;19(13):3244-54. PubMedDOI
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  30. Soignet SL, Frankel SR, Douer D, Tallman MS, Kantarjian H, Calleja E, et al. United States multicenter study of arsenic trioxide in relapsed acute promyelocytic leukemia. J Clin Oncol. 2001;19(18):3852-60. PubMedDOI
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  31. Byrd JC, Mrózek K, Dodge RK, Carroll AJ, Edwards CG, Arthur DC, et al. Pretreatment cytogenetic abnormalities are predictive of induction success, cumulative incidence of relapse, and overall survival in adult patients with de novo acute myeloid leukemia: results from Cancer and Leukemia Group B (CALGB 8461). Blood. 2002;100(13):4325-36. PubMedDOI
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  32. Tallman MS, Andersen JW, Schiffer CA, Appelbaum FR, Feusner JH, Woods WG, et al. All-trans retinoic acid in acute promyelocytic leukemia: long-term outcome and prognostic factor analysis from the North American Intergroup protocol. Blood. 2002;100(13):4298-302. PubMedDOI
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  33. Degos L. The history of acute promyelocytic leukaemia. Br J Haematol. 2003;122(4):539-53. PubMedDOI
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  34. European Medicines Agency (EMEA). Trisenox: EPAR scientific discussion, 2005 (initial authorisation, application February 2001). Source
  35. Neubauer A, Maharry K, Mrózek K, Thiede C, Marcucci G, Paschka P, et al. Patients with acute myeloid leukemia and RAS mutations benefit most from postremission high-dose cytarabine: a Cancer and Leukemia Group B study. J Clin Oncol. 2008;26(28):4603-9. PubMedDOI
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  36. Wang ZY, Chen Z. Acute promyelocytic leukemia: from highly fatal to highly curable. Blood. 2008;111(5):2505-15. PubMedDOI
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  37. Koreth J, Schlenk R, Kopecky KJ, Honda S, Sierra J, Djulbegovic BJ, et al. Allogeneic stem cell transplantation for acute myeloid leukemia in first complete remission: systematic review and meta-analysis of prospective clinical trials. JAMA. 2009;301(22):2349-61. PubMedDOI
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  38. Döhner H, Estey EH, Amadori S, Appelbaum FR, Büchner T, Burnett AK, et al. Diagnosis and management of acute myeloid leukemia in adults: recommendations from an international expert panel, on behalf of the European LeukemiaNet. Blood. 2010;115(3):453-74. PubMedDOI
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  39. Fenaux P, Mufti GJ, Hellström-Lindberg E, Santini V, Gattermann N, Germing U, et al. Azacitidine prolongs overall survival compared with conventional care regimens in elderly patients with low bone marrow blast count acute myeloid leukemia. J Clin Oncol. 2010;28(4):562-9. PubMedDOI
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  40. Pfizer Inc. Pfizer prepares for voluntary withdrawal of U.S. new drug application and for discontinuation of commercial availability of Mylotarg. Press release, 21 June 2010 (manufacturer document, not an FDA record). Source
  41. Avvisati G, Lo-Coco F, Paoloni FP, Petti MC, Diverio D, Vignetti M, et al. AIDA 0493 protocol for newly diagnosed acute promyelocytic leukemia: very long-term results and role of maintenance. Blood. 2011;117(18):4716-25. PubMedDOI
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  42. US Food and Drug Administration. Wyeth Pharmaceuticals, Inc.; Withdrawal of Approval of a New Drug Application for MYLOTARG. Federal Register 2011 Nov 28;76(228):72955 (FR Doc 2011-30473). Source
  43. Park JH, Qiao B, Panageas KS, Schymura MJ, Jurcic JG, Rosenblat TL, et al. Early death rate in acute promyelocytic leukemia remains high despite all-trans retinoic acid. Blood. 2011;118(5):1248-54. PubMedDOI
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  44. Castaigne S, Pautas C, Terré C, Raffoux E, Bordessoule D, Bastie JN, et al. Effect of gemtuzumab ozogamicin on survival of adult patients with de-novo acute myeloid leukaemia (ALFA-0701): a randomised, open-label, phase 3 study. Lancet. 2012;379(9825):1508-16. PubMedDOI
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  45. European Medicines Agency. Dacogen (decitabine): European public assessment report (EPAR) page. Marketing authorisation issued 20/09/2012; page last updated 09/12/2025. Page read 2026-10-20. Source
  46. Kantarjian HM, Thomas XG, Dmoszynska A, Wierzbowska A, Mazur G, Mayer J, et al. Multicenter, randomized, open-label, phase III trial of decitabine versus patient choice, with physician advice, of either supportive care or low-dose cytarabine for the treatment of older patients with newly diagnosed acute myeloid leukemia. J Clin Oncol. 2012;30(21):2670-7. PubMedDOI
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  47. Lo-Coco F, Avvisati G, Vignetti M, Thiede C, Orlando SM, Iacobelli S, et al. Retinoic acid and arsenic trioxide for acute promyelocytic leukemia. N Engl J Med. 2013;369(2):111-21. PubMedDOI
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  48. Petersdorf SH, Kopecky KJ, Slovak M, Willman C, Nevill T, Brandwein J, et al. A phase 3 study of gemtuzumab ozogamicin during induction and postconsolidation therapy in younger patients with acute myeloid leukemia. Blood. 2013;121(24):4854-60. PubMedDOI
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  49. Hills RK, Castaigne S, Appelbaum FR, Delaunay J, Petersdorf S, Othus M, et al. Addition of gemtuzumab ozogamicin to induction chemotherapy in adult patients with acute myeloid leukaemia: a meta-analysis of individual patient data from randomised controlled trials. Lancet Oncol. 2014;15(9):986-96. PubMedDOI
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  50. Burnett AK, Russell NH, Hills RK, Bowen D, Kell J, Knapper S, et al. Arsenic trioxide and all-trans retinoic acid treatment for acute promyelocytic leukaemia in all risk groups (AML17): results of a randomised, controlled, phase 3 trial. Lancet Oncol. 2015;16(13):1295-305. PubMedDOI
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  51. Dombret H, Seymour JF, Butrym A, Wierzbowska A, Selleslag D, Jang JH, et al. International phase 3 study of azacitidine vs conventional care regimens in older patients with newly diagnosed AML with >30% blasts. Blood. 2015;126(3):291-9. PubMedDOI
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  52. Arber DA, Orazi A, Hasserjian R, Thiele J, Borowitz MJ, Le Beau MM, et al. The 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia. Blood. 2016;127(20):2391-405. PubMedDOI
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  53. Ivey A, Hills RK, Simpson MA, Jovanovic JV, Gilkes A, Grech A, et al. Assessment of Minimal Residual Disease in Standard-Risk AML. N Engl J Med. 2016;374(5):422-33. PubMedDOI
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  54. Döhner H, Estey E, Grimwade D, Amadori S, Appelbaum FR, Büchner T, et al. Diagnosis and management of AML in adults: 2017 ELN recommendations from an international expert panel. Blood. 2017;129(4):424-447. PubMedDOI
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  55. European Medicines Agency. Rydapt (midostaurin): European public assessment report (EPAR) page. Marketing authorisation issued 18/09/2017; page last updated 14/01/2026. Page read 2026-10-20. Source
  56. US Food and Drug Administration. NDA approval letter, Idhifa (enasidenib) tablets, NDA 209606, Celgene Corporation; electronic signature dated 08/01/2017. Text read 2026-10-20. Source
  57. US Food and Drug Administration. BLA approval letter, BLA 761060/Original #1 and Original #2, MYLOTARG (gemtuzumab ozogamicin), Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. Electronically signed 1 September 2017. Source
  58. US Food and Drug Administration. NDA approval letter, Rydapt (midostaurin) capsules, NDA 207997 Original #1 and #2, Novartis Pharmaceuticals Corporation; electronic signature dated 04/28/2017. Text read 2026-10-20. Source
  59. US Food and Drug Administration. NDA approval letter, NDA 209401, VYXEOS (daunorubicin and cytarabine) liposome for injection, Celator Pharmaceuticals, Inc. (a Jazz Pharmaceuticals Company). Electronically signed 3 August 2017. Source
  60. Platzbecker U, Avvisati G, Cicconi L, Thiede C, Paoloni F, Vignetti M, et al. Improved Outcomes With Retinoic Acid and Arsenic Trioxide Compared With Retinoic Acid and Chemotherapy in Non-High-Risk Acute Promyelocytic Leukemia: Final Results of the Randomized Italian-German APL0406 Trial. J Clin Oncol. 2017;35(6):605-612. PubMedDOI
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  61. Stein EM, DiNardo CD, Pollyea DA, Fathi AT, Roboz GJ, Altman JK, et al. Enasidenib in mutant IDH2 relapsed or refractory acute myeloid leukemia. Blood. 2017;130(6):722-731. PubMedDOI
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  62. Stone RM, Mandrekar SJ, Sanford BL, Laumann K, Geyer S, Bloomfield CD, et al. Midostaurin plus Chemotherapy for Acute Myeloid Leukemia with a FLT3 Mutation. N Engl J Med. 2017;377(5):454-464. PubMedDOI
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  63. DiNardo CD, Stein EM, de Botton S, Roboz GJ, Altman JK, Mims AS, et al. Durable Remissions with Ivosidenib in IDH1-Mutated Relapsed or Refractory AML. N Engl J Med. 2018;378(25):2386-2398. PubMedDOI
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  64. European Medicines Agency. Mylotarg: EPAR (medicine overview and product details). Marketing authorisation issued 19/04/2018; opinion adopted 22/02/2018; page last updated 16/10/2026. Source
  65. European Medicines Agency. Vyxeos liposomal: EPAR (medicine overview and product details). Marketing authorisation issued 23/08/2018; opinion adopted 26/04/2018; page last updated 04/08/2026. Source
  66. US Food and Drug Administration. NDA approval letter, NDA 210656, DAURISMO (glasdegib), Pfizer, Inc.; electronically signed 21 November 2018. Text read 2026-10-21. Source
  67. US Food and Drug Administration. NDA approval letter, Tibsovo (ivosidenib) tablets, NDA 211192, Agios Pharmaceuticals, Inc.; electronic signature dated 07/20/2018. Text read 2026-10-20. Source
  68. US Food and Drug Administration. TRISENOX (arsenic trioxide) injection, full prescribing information accompanying supplement NDA 021248/S-015 (Reference ID 4206524), January 2018. Source
  69. US Food and Drug Administration. Supplement approval letter, NDA 021248/S-015, Trisenox (arsenic trioxide) injection, electronic signature date 12 January 2018. Source
  70. US Food and Drug Administration. Accelerated approval letter, Venclexta (venetoclax) tablets, NDA 208573/S-009, AbbVie Inc.; electronic signature dated 11/21/2018. Text read 2026-10-20. Source
  71. US Food and Drug Administration. NDA approval (replacement) letter, Xospata (gilteritinib) tablets, NDA 211349, Astellas Pharma US, Inc.; electronic signature dated 11/28/2018. Text read 2026-10-20. Source
  72. Jongen-Lavrencic M, Grob T, Hanekamp D, Kavelaars FG, Al Hinai A, Zeilemaker A, et al. Molecular Minimal Residual Disease in Acute Myeloid Leukemia. N Engl J Med. 2018;378(13):1189-1199. PubMedDOI
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  73. Lancet JE, Uy GL, Cortes JE, Newell LF, Lin TL, Ritchie EK, et al. CPX-351 (cytarabine and daunorubicin) Liposome for Injection Versus Conventional Cytarabine Plus Daunorubicin in Older Patients With Newly Diagnosed Secondary Acute Myeloid Leukemia. J Clin Oncol. 2018;36(26):2684-2692. PubMedDOI
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  74. DiNardo CD, Pratz K, Pullarkat V, Jonas BA, Arellano M, Becker PS, et al. Venetoclax combined with decitabine or azacitidine in treatment-naive, elderly patients with acute myeloid leukemia. Blood. 2019;133(1):7-17. PubMedDOI
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  75. European Medicines Agency. Xospata (gilteritinib): European public assessment report (EPAR) page. Marketing authorisation issued 24/10/2019; page last updated 16/01/2026. Page read 2026-10-20. Source
  76. US Food and Drug Administration. Supplement approval letter, Tibsovo (ivosidenib) tablets, NDA 211192/S-001, Agios Pharmaceuticals, Inc.; electronic signature dated 05/02/2019. Text read 2026-10-20. Source
  77. Perl AE, Martinelli G, Cortes JE, Neubauer A, Berman E, Paolini S, et al. Gilteritinib or Chemotherapy for Relapsed or Refractory FLT3-Mutated AML. N Engl J Med. 2019;381(18):1728-1740. PubMedDOI
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  78. Sanz MA, Fenaux P, Tallman MS, Estey EH, Löwenberg B, Naoe T, et al. Management of acute promyelocytic leukemia: updated recommendations from an expert panel of the European LeukemiaNet. Blood. 2019;133(15):1630-1643. PubMedDOI
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  79. DiNardo CD, Jonas BA, Pullarkat V, Thirman MJ, Garcia JS, Wei AH, et al. Azacitidine and Venetoclax in Previously Untreated Acute Myeloid Leukemia. N Engl J Med. 2020;383(7):617-629. PubMedDOI
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  80. European Medicines Agency. Daurismo (glasdegib): European public assessment report (EPAR) page. Marketing authorisation issued 26/06/2020; opinion adopted 30/04/2020. Page last updated 07/05/2025; read 2026-10-21. Source
  81. European Medicines Agency. Idhifa (enasidenib): withdrawn-application page. The page states that Celgene Europe B.V. withdrew its application for a marketing authorisation for adults with acute myeloid leukaemia on 6 December 2019. Page last updated 07/02/2020; read 2026-10-21. Source
  82. US Food and Drug Administration. NDA approval letter, Onureg (azacitidine) tablets, NDA 214120, Celgene Corporation; electronic signature dated 09/01/2020. Text read 2026-10-20. Source
  83. US Food and Drug Administration. Supplement approval and fulfillment of postmarketing requirement letter, Venclexta (venetoclax) tablets, NDA 208573/S-020 and S-021, AbbVie Inc.; electronic signature dated 10/16/2020. Text read 2026-10-20. Source
  84. Heuser M, Ofran Y, Boissel N, Brunet Mauri S, Craddock C, Janssen J, et al. Acute myeloid leukaemia in adult patients: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2020;31(6):697-712. PubMedDOI
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  85. Short NJ, Zhou S, Fu C, Berry DA, Walter RB, Freeman SD, et al. Association of Measurable Residual Disease With Survival Outcomes in Patients With Acute Myeloid Leukemia: A Systematic Review and Meta-analysis. JAMA Oncol. 2020;6(12):1890-1899. PubMedDOI
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  86. Wei AH, Montesinos P, Ivanov V, DiNardo CD, Novak J, Laribi K, et al. Venetoclax plus LDAC for newly diagnosed AML ineligible for intensive chemotherapy: a phase 3 randomized placebo-controlled trial. Blood. 2020;135(24):2137-2145. PubMedDOI
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  87. Wei AH, Döhner H, Pocock C, Montesinos P, Afanasyev B, Dombret H, et al. Oral Azacitidine Maintenance Therapy for Acute Myeloid Leukemia in First Remission. N Engl J Med. 2020;383(26):2526-2537. PubMedDOI
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  88. European Medicines Agency. Onureg (azacitidine): European public assessment report (EPAR) page. Marketing authorisation issued 17/06/2021; page last updated 03/09/2026. Page read 2026-10-20. Source
  89. European Medicines Agency. Venclyxto: EPAR - Procedural steps taken and scientific information after authorisation (archive version). Variation II/0030, extension of indication for venetoclax in combination with hypomethylating agents for newly diagnosed AML ineligible for intensive chemotherapy: CHMP opinion 22/04/2021, Commission decision 19/05/2021. Read 2026-10-21. Source
  90. US Food and Drug Administration. Supplement approval letter, NDA 209401/S-006, VYXEOS (daunorubicin and cytarabine) liposome for injection, Celator Pharmaceuticals, Inc. (a Jazz Pharmaceuticals Company); electronically signed 30 March 2021. Text read 2026-10-21. Source
  91. Heuser M, Freeman SD, Ossenkoppele GJ, Buccisano F, Hourigan CS, Ngai LL, et al. 2021 Update on MRD in acute myeloid leukemia: a consensus document from the European LeukemiaNet MRD Working Party. Blood. 2021;138(26):2753-2767. PubMedDOI
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  92. Lancet JE, Uy GL, Newell LF, Lin TL, Ritchie EK, Stuart RK, et al. CPX-351 versus 7+3 cytarabine and daunorubicin chemotherapy in older adults with newly diagnosed high-risk or secondary acute myeloid leukaemia: 5-year results of a randomised, open-label, multicentre, phase 3 trial. Lancet Haematol. 2021;8(7):e481-e491. PubMedDOI
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  93. Arber DA, Orazi A, Hasserjian RP, Borowitz MJ, Calvo KR, Kvasnicka HM, et al. International Consensus Classification of Myeloid Neoplasms and Acute Leukemias: integrating morphologic, clinical, and genomic data. Blood. 2022;140(11):1200-1228. PubMedDOI
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  94. Döhner H, Wei AH, Appelbaum FR, Craddock C, DiNardo CD, Dombret H, et al. Diagnosis and management of AML in adults: 2022 recommendations from an international expert panel on behalf of the ELN. Blood. 2022;140(12):1345-1377. PubMedDOI
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  95. US Food and Drug Administration. NDA approval letter, Rezlidhia (olutasidenib) capsules, NDA 215814, Forma Therapeutics, Inc.; electronic signature dated 12/01/2022 (scanned document; text read from the file's text layer, with OCR noise). Read 2026-10-20. Source
  96. US Food and Drug Administration. Supplement approval letter, Tibsovo (ivosidenib) tablets, NDA 211192/S-009, Servier Pharmaceuticals LLC; electronic signature dated 05/25/2022. Text read 2026-10-20. Source
  97. Khoury JD, Solary E, Abla O, Akkari Y, Alaggio R, Apperley JF, et al. The 5th edition of the World Health Organization Classification of Haematolymphoid Tumours: Myeloid and Histiocytic/Dendritic Neoplasms. Leukemia. 2022;36(7):1703-1719. PubMedDOI
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  98. Montesinos P, Recher C, Vives S, Zarzycka E, Wang J, Bertani G, et al. Ivosidenib and Azacitidine in IDH1-Mutated Acute Myeloid Leukemia. N Engl J Med. 2022;386(16):1519-1531. PubMedDOI
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  99. de Botton S, Fenaux P, Yee K, Récher C, Wei AH, Montesinos P, et al. Olutasidenib (FT-2102) induces durable complete remissions in patients with relapsed or refractory IDH1-mutated AML. Blood Adv. 2023;7(13):3117-3127. PubMedDOI
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  100. European Medicines Agency. Tibsovo (ivosidenib): European public assessment report (EPAR) page. Marketing authorisation issued 04/05/2023; page last updated 25/02/2026. Page read 2026-10-20. Source
  101. European Medicines Agency. Vanflyta (quizartinib): European public assessment report (EPAR) page. Marketing authorisation issued 06/11/2023; page last updated 19/08/2026. Page read 2026-10-20. Source
  102. Erba HP, Montesinos P, Kim HJ, Patkowska E, Vrhovac R, Žák P, et al. Quizartinib plus chemotherapy in newly diagnosed patients with FLT3-internal-tandem-duplication-positive acute myeloid leukaemia (QuANTUM-First): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2023;401(10388):1571-1583. PubMedDOI
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  103. US Food and Drug Administration. NDA approval letter, Vanflyta (quizartinib) tablets, NDA 216993, Daiichi Sankyo, Inc.; electronic signature dated 07/20/2023. Text read 2026-10-20. Source
  104. Issa GC, Aldoss I, DiPersio J, Cuglievan B, Stone R, Arellano M, et al. The menin inhibitor revumenib in KMT2A-rearranged or NPM1-mutant leukaemia. Nature. 2023;615(7954):920-924. PubMedDOI
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  105. European Medicines Agency. Vidaza (azacitidine): European public assessment report (EPAR) page. Marketing authorisation issued 17/12/2008 (the page lists AML indications but shows no date for them). Page last updated 05/11/2024; read 2026-10-21. Source
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