Перейти к содержимому
Bending the Curve Trial by Trial
?EN

Назад: Хронический лимфолейкоз

Список литературы: Хронический лимфолейкоз

126 источников, процитированных на этой странице. Ссылки ведут к первоисточнику.

  1. GALTON DA, ISRAELS LG, NABARRO JD, TILL M. Clinical trials of p-(di-2-chloroethylamino)-phenylbutyric acid (CB 1348) in malignant lymphoma. Br Med J. 1955;2(4949):1172-6. PubMedDOI
    ЦитироватьЗагрузка…
  2. Han T, Ezdinli EZ, Shimaoka K, Desai DV. Chlorambucil vs. combined chlorambucil-corticosteroid therapy in chronic lymphocytic leukemia. Cancer. 1973;31(3):502-8. PubMedDOI
    ЦитироватьЗагрузка…
  3. Rai KR, Sawitsky A, Cronkite EP, Chanana AD, Levy RN, Pasternack BS. Clinical staging of chronic lymphocytic leukemia. Blood. 1975;46(2):219-34. PubMed
    ЦитироватьЗагрузка…
  4. Binet JL, Leporrier M, Dighiero G, Charron D, D'Athis P, Vaugier G, et al. A clinical staging system for chronic lymphocytic leukemia: prognostic significance. Cancer. 1977;40(2):855-64. PubMedDOI
    ЦитироватьЗагрузка…
  5. Binet JL, Auquier A, Dighiero G, Chastang C, Piguet H, Goasguen J, et al. A new prognostic classification of chronic lymphocytic leukemia derived from a multivariate survival analysis. Cancer. 1981;48(1):198-206. PubMedDOI
    ЦитироватьЗагрузка…
  6. Keating MJ, Kantarjian H, O'Brien S, Koller C, Talpaz M, Schachner J, et al. Fludarabine: a new agent with marked cytoreductive activity in untreated chronic lymphocytic leukemia. J Clin Oncol. 1991;9(1):44-9. PubMedDOI
    ЦитироватьЗагрузка…
  7. CLL Trialists' Collaborative Group. Chemotherapeutic options in chronic lymphocytic leukemia: a meta-analysis of the randomized trials. J Natl Cancer Inst. 1999;91(10):861-8. PubMedDOI
    ЦитироватьЗагрузка…
  8. Damle RN, Wasil T, Fais F, Ghiotto F, Valetto A, Allen SL, et al. Ig V gene mutation status and CD38 expression as novel prognostic indicators in chronic lymphocytic leukemia. Blood. 1999;94(6):1840-7. PubMed
    ЦитироватьЗагрузка…
  9. Hamblin TJ, Davis Z, Gardiner A, Oscier DG, Stevenson FK. Unmutated Ig V(H) genes are associated with a more aggressive form of chronic lymphocytic leukemia. Blood. 1999;94(6):1848-54. PubMed
    ЦитироватьЗагрузка…
  10. Döhner H, Stilgenbauer S, Benner A, Leupolt E, Kröber A, Bullinger L, et al. Genomic aberrations and survival in chronic lymphocytic leukemia. N Engl J Med. 2000;343(26):1910-6. PubMedDOI
    ЦитироватьЗагрузка…
  11. Rai KR, Peterson BL, Appelbaum FR, Kolitz J, Elias L, Shepherd L, et al. Fludarabine compared with chlorambucil as primary therapy for chronic lymphocytic leukemia. N Engl J Med. 2000;343(24):1750-7. PubMedDOI
    ЦитироватьЗагрузка…
  12. U.S. Food and Drug Administration, Center for Biologics Evaluation and Research. Clinical review of the Campath (alemtuzumab) biologics license application, STN 103948, 4 May 2001 (Drugs@FDA drug approval package). Источник
  13. U.S. Food and Drug Administration, Center for Biologics Evaluation and Research. Licensing action letter, BL 103948/0, alemtuzumab (Campath), Millennium and ILEX Partners. 7 May 2001. Источник
  14. Leporrier M, Chevret S, Cazin B, Boudjerra N, Feugier P, Desablens B, et al. Randomized comparison of fludarabine, CAP, and ChOP in 938 previously untreated stage B and C chronic lymphocytic leukemia patients. Blood. 2001;98(8):2319-25. PubMedDOI
    ЦитироватьЗагрузка…
  15. Keating MJ, Flinn I, Jain V, Binet JL, Hillmen P, Byrd J, et al. Therapeutic role of alemtuzumab (Campath-1H) in patients who have failed fludarabine: results of a large international study. Blood. 2002;99(10):3554-61. PubMedDOI
    ЦитироватьЗагрузка…
  16. Keating MJ, O'Brien S, Albitar M, Lerner S, Plunkett W, Giles F, et al. Early results of a chemoimmunotherapy regimen of fludarabine, cyclophosphamide, and rituximab as initial therapy for chronic lymphocytic leukemia. J Clin Oncol. 2005;23(18):4079-88. PubMedDOI
    ЦитироватьЗагрузка…
  17. Eichhorst BF, Busch R, Hopfinger G, Pasold R, Hensel M, Steinbrecher C, et al. Fludarabine plus cyclophosphamide versus fludarabine alone in first-line therapy of younger patients with chronic lymphocytic leukemia. Blood. 2006;107(3):885-91. PubMedDOI
    ЦитироватьЗагрузка…
  18. U.S. Food and Drug Administration. Supplement approval letter, BL 103948/5070, alemtuzumab (Campath), Genzyme. Approved 19 September 2007 (the stamped date is partly legible; the letter cites a commitment letter of 19 September 2007 and the Drugs@FDA approval history gives 09/19/2007). Источник
  19. Hillmen P, Skotnicki AB, Robak T, Jaksic B, Dmoszynska A, Wu J, et al. Alemtuzumab compared with chlorambucil as first-line therapy for chronic lymphocytic leukemia. J Clin Oncol. 2007;25(35):5616-23. PubMedDOI
    ЦитироватьЗагрузка…
  20. U.S. Food and Drug Administration. Approval letter, NDA 22-273, fludarabine phosphate 10 mg tablets (Oforta), Antisoma. 18 December 2008. Источник
  21. Hallek M, Cheson BD, Catovsky D, Caligaris-Cappio F, Dighiero G, Döhner H, et al. Guidelines for the diagnosis and treatment of chronic lymphocytic leukemia: a report from the International Workshop on Chronic Lymphocytic Leukemia updating the National Cancer Institute-Working Group 1996 guidelines. Blood. 2008;111(12):5446-56. PubMedDOI
    ЦитироватьЗагрузка…
  22. U.S. Food and Drug Administration. Fludara (fludarabine phosphate) for injection, prescribing information, NDA 020038/S-033 (action date 29 July 2010). Источник
  23. U.S. Food and Drug Administration. Approval letter, STN BL 103705/5311, Rituxan (rituximab). 18 February 2010. Источник
  24. U.S. Food and Drug Administration. Approval letter, STN BL 103705/5312, Rituxan (rituximab). 18 February 2010. Источник
  25. Hallek M, Fischer K, Fingerle-Rowson G, Fink AM, Busch R, Mayer J, et al. Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: a randomised, open-label, phase 3 trial. Lancet. 2010;376(9747):1164-74. PubMedDOI
    ЦитироватьЗагрузка…
  26. Zenz T, Eichhorst B, Busch R, Denzel T, Häbe S, Winkler D, et al. TP53 mutation and survival in chronic lymphocytic leukemia. J Clin Oncol. 2010;28(29):4473-9. PubMedDOI
    ЦитироватьЗагрузка…
  27. U.S. Food and Drug Administration. Leukeran (chlorambucil) tablets, prescribing information, NDA 010669/S-032 (action date 28 October 2011). Источник
  28. Porter DL, Levine BL, Kalos M, Bagg A, June CH. Chimeric antigen receptor-modified T cells in chronic lymphoid leukemia. N Engl J Med. 2011;365(8):725-33. PubMedDOI
    ЦитироватьЗагрузка…
  29. Byrd JC, Furman RR, Coutre SE, Flinn IW, Burger JA, Blum KA, et al. Targeting BTK with ibrutinib in relapsed chronic lymphocytic leukemia. N Engl J Med. 2013;369(1):32-42. PubMedDOI
    ЦитироватьЗагрузка…
  30. U.S. Food and Drug Administration. BLA approval letter, BLA 125486/0, Gazyva (obinutuzumab). e-signed 1 November 2013. Источник
  31. Byrd JC, Brown JR, O'Brien S, Barrientos JC, Kay NE, Reddy NM, et al. Ibrutinib versus ofatumumab in previously treated chronic lymphoid leukemia. N Engl J Med. 2014;371(3):213-23. PubMedDOI
    ЦитироватьЗагрузка…
  32. US Food and Drug Administration. Accelerated approval letter, Imbruvica (ibrutinib) capsules, NDA 205552/Original 2 (CLL after at least one prior therapy), Pharmacyclics, Inc.; electronic signature dated 02/12/2014. Источник
  33. US Food and Drug Administration. Supplement approval letter (Subpart H fulfilled), Imbruvica (ibrutinib) capsules, NDA 205552/S-001, Pharmacyclics, Inc.; electronic signature dated 07/28/2014. Источник
  34. US Food and Drug Administration. NDA approval letter, Zydelig (idelalisib) tablets, NDA 206545 (relapsed CLL in combination with rituximab), Gilead Sciences, Inc.; electronic signature dated 07/23/2014. Источник
  35. Furman RR, Sharman JP, Coutre SE, Cheson BD, Pagel JM, Hillmen P, et al. Idelalisib and rituximab in relapsed chronic lymphocytic leukemia. N Engl J Med. 2014;370(11):997-1007. PubMedDOI
    ЦитироватьЗагрузка…
  36. Goede V, Fischer K, Busch R, Engelke A, Eichhorst B, Wendtner CM, et al. Obinutuzumab plus chlorambucil in patients with CLL and coexisting conditions. N Engl J Med. 2014;370(12):1101-10. PubMedDOI
    ЦитироватьЗагрузка…
  37. Burger JA, Tedeschi A, Barr PM, Robak T, Owen C, Ghia P, et al. Ibrutinib as Initial Therapy for Patients with Chronic Lymphocytic Leukemia. N Engl J Med. 2015;373(25):2425-37. PubMedDOI
    ЦитироватьЗагрузка…
  38. European Medicines Agency, Committee for Medicinal Products for Human Use. Appendix 4 to the guideline on the evaluation of anticancer medicinal products in man: condition specific guidance, EMA/CHMP/703715/2012 Rev. 2; adopted 17 December 2015, in effect 1 July 2016. Источник
  39. International CLL-IPI working group. An international prognostic index for patients with chronic lymphocytic leukaemia (CLL-IPI): a meta-analysis of individual patient data. Lancet Oncol. 2016;17(6):779-790. PubMedDOI
    ЦитироватьЗагрузка…
  40. European Medicines Agency. Venclyxto: EPAR public assessment report, EMA/725631/2016, 13 October 2016 (CHMP opinion for a conditional marketing authorisation). Источник
  41. US Food and Drug Administration. Supplement approval letter, Imbruvica (ibrutinib) capsules, NDA 205552/S-007 (frontline indication for CLL), Pharmacyclics LLC; electronic signature dated 03/04/2016. Источник
  42. US Food and Drug Administration. Approval letter, Venclexta (venetoclax) tablets, NDA 208573, AbbVie Inc.; electronic signature 11 April 2016. Источник
  43. Kwok M, Rawstron AC, Varghese A, Evans PA, O'Connor SJ, Doughty C, et al. Minimal residual disease is an independent predictor for 10-year survival in CLL. Blood. 2016;128(24):2770-2773. PubMedDOI
    ЦитироватьЗагрузка…
  44. Roberts AW, Davids MS, Pagel JM, Kahl BS, Puvvada SD, Gerecitano JF, et al. Targeting BCL2 with Venetoclax in Relapsed Chronic Lymphocytic Leukemia. N Engl J Med. 2016;374(4):311-22. PubMedDOI
    ЦитироватьЗагрузка…
  45. Stilgenbauer S, Eichhorst B, Schetelig J, Coutre S, Seymour JF, Munir T, et al. Venetoclax in relapsed or refractory chronic lymphocytic leukaemia with 17p deletion: a multicentre, open-label, phase 2 study. Lancet Oncol. 2016;17(6):768-778. PubMedDOI
    ЦитироватьЗагрузка…
  46. Thompson PA, Tam CS, O'Brien SM, Wierda WG, Stingo F, Plunkett W, et al. Fludarabine, cyclophosphamide, and rituximab treatment achieves long-term disease-free survival in IGHV-mutated chronic lymphocytic leukemia. Blood. 2016;127(3):303-9. PubMedDOI
    ЦитироватьЗагрузка…
  47. European Medicines Agency. Venclyxto: CHMP variation assessment report, procedure EMEA/H/C/004106/II/0011, EMA/CHMP/717206/2018, 20 September 2018. Источник
  48. US Food and Drug Administration. NDA approval letter, Copiktra (duvelisib) capsules, NDA 211155/Original 2 (relapsed or refractory CLL/SLL after at least two prior therapies), Verastem Inc.; electronic signature dated 09/24/2018. Источник
  49. US Food and Drug Administration. Venclexta (venetoclax) prescribing information, revised 06/2018, NDA 208573/S-004 and S-005. Источник
  50. US Food and Drug Administration. Supplement approval letter, Venclexta (venetoclax), NDA 208573/S-004 and S-005, AbbVie Inc.; electronic signature 8 June 2018. Источник
  51. Flinn IW, Hillmen P, Montillo M, Nagy Z, Illés Á, Etienne G, et al. The phase 3 DUO trial: duvelisib vs ofatumumab in relapsed and refractory CLL/SLL. Blood. 2018;132(23):2446-2455. PubMedDOI
    ЦитироватьЗагрузка…
  52. Hallek M, Cheson BD, Catovsky D, Caligaris-Cappio F, Dighiero G, Döhner H, et al. iwCLL guidelines for diagnosis, indications for treatment, response assessment, and supportive management of CLL. Blood. 2018;131(25):2745-2760. PubMedDOI
    ЦитироватьЗагрузка…
  53. Seymour JF, Kipps TJ, Eichhorst B, Hillmen P, D'Rozario J, Assouline S, et al. Venetoclax-Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia. N Engl J Med. 2018;378(12):1107-1120. PubMedDOI
    ЦитироватьЗагрузка…
  54. Stilgenbauer S, Eichhorst B, Schetelig J, Hillmen P, Seymour JF, Coutre S, et al. Venetoclax for Patients With Chronic Lymphocytic Leukemia With 17p Deletion: Results From the Full Population of a Phase II Pivotal Trial. J Clin Oncol. 2018;36(19):1973-1980. PubMedDOI
    ЦитироватьЗагрузка…
  55. Woyach JA, Ruppert AS, Heerema NA, Zhao W, Booth AM, Ding W, et al. Ibrutinib Regimens versus Chemoimmunotherapy in Older Patients with Untreated CLL. N Engl J Med. 2018;379(26):2517-2528. PubMedDOI
    ЦитироватьЗагрузка…
  56. US Food and Drug Administration. Supplement approval letter, Calquence (acalabrutinib) capsules, NDA 210259/S-006 and S-007 (CLL or SLL), AstraZeneca UK Limited c/o Acerta Pharma; electronic signature dated 11/21/2019. Источник
  57. US Food and Drug Administration. Supplement approval letter, Venclexta (venetoclax), NDA 208573/S-013, AbbVie Inc.; electronic signature 15 May 2019. Источник
  58. Fischer K, Al-Sawaf O, Bahlo J, Fink AM, Tandon M, Dixon M, et al. Venetoclax and Obinutuzumab in Patients with CLL and Coexisting Conditions. N Engl J Med. 2019;380(23):2225-2236. PubMedDOI
    ЦитироватьЗагрузка…
  59. Shanafelt TD, Wang XV, Kay NE, Hanson CA, O'Brien S, Barrientos J, et al. Ibrutinib-Rituximab or Chemoimmunotherapy for Chronic Lymphocytic Leukemia. N Engl J Med. 2019;381(5):432-443. PubMedDOI
    ЦитироватьЗагрузка…
  60. Ghia P, Pluta A, Wach M, Lysak D, Kozak T, Simkovic M, et al. ASCEND: Phase III, Randomized Trial of Acalabrutinib Versus Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia. J Clin Oncol. 2020;38(25):2849-2861. PubMedDOI
    ЦитироватьЗагрузка…
  61. Herling CD, Cymbalista F, Groß-Ophoff-Müller C, Bahlo J, Robrecht S, Langerbeins P, et al. Early treatment with FCR versus watch and wait in patients with stage Binet A high-risk chronic lymphocytic leukemia (CLL): a randomized phase 3 trial. Leukemia. 2020;34(8):2038-2050. PubMedDOI
    ЦитироватьЗагрузка…
  62. Sharman JP, Egyed M, Jurczak W, Skarbnik A, Pagel JM, Flinn IW, et al. Acalabrutinib with or without obinutuzumab versus chlorambucil and obinutuzmab for treatment-naive chronic lymphocytic leukaemia (ELEVATE TN): a randomised, controlled, phase 3 trial. Lancet. 2020;395(10232):1278-1291. PubMedDOI
    ЦитироватьЗагрузка…
  63. Byrd JC, Hillmen P, Ghia P, Kater AP, Chanan-Khan A, Furman RR, et al. Acalabrutinib Versus Ibrutinib in Previously Treated Chronic Lymphocytic Leukemia: Results of the First Randomized Phase III Trial. J Clin Oncol. 2021;39(31):3441-3452. PubMedDOI
    ЦитироватьЗагрузка…
  64. Wierda WG, Rawstron A, Cymbalista F, Badoux X, Rossi D, Brown JR, et al. Measurable residual disease in chronic lymphocytic leukemia: expert review and consensus recommendations. Leukemia. 2021;35(11):3059-3072. PubMedDOI
    ЦитироватьЗагрузка…
  65. Barr PM, Owen C, Robak T, Tedeschi A, Bairey O, Burger JA, et al. Up to 8-year follow-up from RESONATE-2: first-line ibrutinib treatment for patients with chronic lymphocytic leukemia. Blood Adv. 2022;6(11):3440-3450. PubMedDOI
    ЦитироватьЗагрузка…
  66. US Food and Drug Administration. Prescribing information, Zydelig (idelalisib) tablets, NDA 205858, revised 2/2022 (Gilead Sciences, Inc.). Источник
  67. Kater AP, Owen C, Moreno C, Follows G, Munir T, Levin MD, et al. Fixed-Duration Ibrutinib-Venetoclax in Patients with Chronic Lymphocytic Leukemia and Comorbidities. NEJM Evid. 2022;1(7):EVIDoa2200006. PubMedDOI
    ЦитироватьЗагрузка…
  68. Langerbeins P, Zhang C, Robrecht S, Cramer P, Fürstenau M, Al-Sawaf O, et al. The CLL12 trial: ibrutinib vs placebo in treatment-naïve, early-stage chronic lymphocytic leukemia. Blood. 2022;139(2):177-187. PubMedDOI
    ЦитироватьЗагрузка…
  69. Tam CS, Brown JR, Kahl BS, Ghia P, Giannopoulos K, Jurczak W, et al. Zanubrutinib versus bendamustine and rituximab in untreated chronic lymphocytic leukaemia and small lymphocytic lymphoma (SEQUOIA): a randomised, controlled, phase 3 trial. Lancet Oncol. 2022;23(8):1031-1043. PubMedDOI
    ЦитироватьЗагрузка…
  70. Brown JR, Eichhorst B, Hillmen P, Jurczak W, Kaźmierczak M, Lamanna N, et al. Zanubrutinib or Ibrutinib in Relapsed or Refractory Chronic Lymphocytic Leukemia. N Engl J Med. 2023;388(4):319-332. PubMedDOI
    ЦитироватьЗагрузка…
  71. Eichhorst B, Niemann CU, Kater AP, Fürstenau M, von Tresckow J, Zhang C, et al. First-Line Venetoclax Combinations in Chronic Lymphocytic Leukemia. N Engl J Med. 2023;388(19):1739-1754. PubMedDOI
    ЦитироватьЗагрузка…
  72. US Food and Drug Administration. Supplement approval letter, Brukinsa (zanubrutinib) capsules, NDA 213217/S-007 (new indication for CLL or SLL), BeiGene USA, Inc.; electronic signature dated 01/19/2023. Источник
  73. US Food and Drug Administration. Accelerated approval letter, Jaypirca (pirtobrutinib) tablets, NDA 216059/S-001 (CLL/SLL after at least two prior lines including a BTK inhibitor and a BCL-2 inhibitor), Loxo Oncology, Inc.; electronic signature dated 12/01/2023. Источник
  74. Hillmen P, Eichhorst B, Brown JR, Lamanna N, O'Brien SM, Tam CS, et al. Zanubrutinib Versus Ibrutinib in Relapsed/Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma: Interim Analysis of a Randomized Phase III Trial. J Clin Oncol. 2023;41(5):1035-1045. PubMedDOI
    ЦитироватьЗагрузка…
  75. Hillmen P, Pitchford A, Bloor A, Broom A, Young M, Kennedy B, et al. Ibrutinib and rituximab versus fludarabine, cyclophosphamide, and rituximab for patients with previously untreated chronic lymphocytic leukaemia (FLAIR): interim analysis of a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2023;24(5):535-552. PubMedDOI
    ЦитироватьЗагрузка…
  76. Mato AR, Woyach JA, Brown JR, Ghia P, Patel K, Eyre TA, et al. Pirtobrutinib after a Covalent BTK Inhibitor in Chronic Lymphocytic Leukemia. N Engl J Med. 2023;389(1):33-44. PubMedDOI
    ЦитироватьЗагрузка…
  77. Niemann CU, Munir T, Moreno C, Owen C, Follows GA, Benjamini O, et al. Fixed-duration ibrutinib-venetoclax versus chlorambucil-obinutuzumab in previously untreated chronic lymphocytic leukaemia (GLOW): 4-year follow-up from a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2023;24(12):1423-1433. PubMedDOI
    ЦитироватьЗагрузка…
  78. Siddiqi T, Maloney DG, Kenderian SS, Brander DM, Dorritie K, Soumerai J, et al. Lisocabtagene maraleucel in chronic lymphocytic leukaemia and small lymphocytic lymphoma (TRANSCEND CLL 004): a multicentre, open-label, single-arm, phase 1-2 study. Lancet. 2023;402(10402):641-654. PubMedDOI
    ЦитироватьЗагрузка…
  79. Al-Sawaf O, Robrecht S, Zhang C, Olivieri S, Chang YM, Fink AM, et al. Venetoclax-obinutuzumab for previously untreated chronic lymphocytic leukemia: 6-year results of the randomized phase 3 CLL14 study. Blood. 2024;144(18):1924-1935. PubMedDOI
    ЦитироватьЗагрузка…
  80. Eichhorst B, Ghia P, Niemann CU, Kater AP, Gregor M, Hallek M, et al. ESMO Clinical Practice Guideline interim update on new targeted therapies in the first line and at relapse of chronic lymphocytic leukaemia. Ann Oncol. 2024;35(9):762-768. PubMedDOI
    ЦитироватьЗагрузка…
  81. US Food and Drug Administration. Replacement supplement approval letter, Breyanzi (lisocabtagene maraleucel), STN BL 125714/205, Juno Therapeutics; letter dated 21 March 2024, effective approval date 14 March 2024. Источник
  82. Fürstenau M, Kater AP, Robrecht S, von Tresckow J, Zhang C, Gregor M, et al. First-line venetoclax combinations versus chemoimmunotherapy in fit patients with chronic lymphocytic leukaemia (GAIA/CLL13): 4-year follow-up from a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2024;25(6):744-759. PubMedDOI
    ЦитироватьЗагрузка…
  83. Brown JR, Seymour JF, Jurczak W, Aw A, Wach M, Illes A, et al. Fixed-Duration Acalabrutinib Combinations in Untreated Chronic Lymphocytic Leukemia. N Engl J Med. 2025;392(8):748-762. PubMedDOI
    ЦитироватьЗагрузка…
  84. European Medicines Agency. Jaypirca: EPAR - Procedural steps taken and scientific information after authorisation (archive version). Variation II/0002, extension of indication to adults with chronic lymphocytic leukaemia previously treated with a BTK inhibitor, based on interim results from study LOXO-BTK-20020 (BRUIN CLL-321): CHMP opinion 27/02/2025, Commission decision 28/03/2025. Read 2026-10-31. Источник
  85. US Food and Drug Administration. Supplement approval letter (Subpart H fulfilled), Jaypirca (pirtobrutinib) tablets, NDA 216059/S-005, Loxo Oncology, Inc.; electronic signature dated 12/03/2025. Источник
  86. Kater AP, Harrup R, Kipps TJ, Eichhorst B, Owen CJ, Assouline S, et al. The MURANO study: final analysis and retreatment/crossover substudy results of VenR for patients with relapsed/refractory CLL. Blood. 2025;145(23):2733-2745. PubMedDOI
    ЦитироватьЗагрузка…
  87. Langerbeins P, Robrecht S, Nieper P, Cramer P, Fürstenau M, Al-Sawaf O, et al. Ibrutinib in Early-Stage Chronic Lymphocytic Leukemia: The Randomized, Placebo-Controlled, Double-Blind, Phase III CLL12 Trial. J Clin Oncol. 2025;43(4):392-402. PubMedDOI
    ЦитироватьЗагрузка…
  88. Sharman JP, Munir T, Grosicki S, Roeker LE, Burke JM, Chen CI, et al. Phase III Trial of Pirtobrutinib Versus Idelalisib/Rituximab or Bendamustine/Rituximab in Covalent Bruton Tyrosine Kinase Inhibitor-Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-321). J Clin Oncol. 2025;43(22):2538-2549. PubMedDOI
    ЦитироватьЗагрузка…
  89. Sharman JP, Munir T, Grosicki S, Roeker LE, Burke JM, Chen CI, et al. Erratum: Phase III Trial of Pirtobrutinib Versus Idelalisib/Rituximab or Bendamustine/Rituximab in Covalent Bruton Tyrosine Kinase Inhibitor-Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-321). J Clin Oncol. 2025;43(23):2658. PubMedDOI
    ЦитироватьЗагрузка…
  90. Sharman JP, Munir T, Grosicki S, Roeker LE, Burke JM, Chen CI, et al. Erratum: Phase III Trial of Pirtobrutinib Versus Idelalisib/Rituximab or Bendamustine/Rituximab in Covalent Bruton Tyrosine Kinase Inhibitor-Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-321). J Clin Oncol. 2025;43(25):2841. PubMedDOI
    ЦитироватьЗагрузка…
  91. ClinicalTrials.gov. NCT00275054 (Rituximab, Fludarabine, and Cyclophosphamide or Observation Alone in Treating Patients With Stage 0, Stage I, or Stage II Chronic Lymphocytic Leukemia). Registry record, accessed 20 October 2026. NCT00275054
  92. ClinicalTrials.gov. NCT01328626. Registry record, accessed 20 October 2026. NCT01328626
  93. ClinicalTrials.gov. NCT02242942 (CLL14). Registry record, accessed 20 October 2026. NCT02242942
  94. ClinicalTrials.gov. NCT02863718 (Ibrutinib in Previously Untreated Binet Stage A Chronic Lymphocytic Leukemia With Risk of Disease Progression; acronym CLL12). Registry record, accessed 20 October 2026. NCT02863718
  95. ClinicalTrials.gov. NCT03331198 (TRANSCEND CLL 004). Registry record, accessed 20 October 2026. NCT03331198
  96. ClinicalTrials.gov. NCT03836261 (AMPLIFY). Registry record, accessed 20 October 2026. NCT03836261
  97. ClinicalTrials.gov. NCT04269902 (EVOLVE CLL/SLL, SWOG S1925). Registry record, API v2, accessed 21 October 2026. NCT04269902
  98. ClinicalTrials.gov. NCT04965493 (BRUIN CLL-322). Registry record, accessed 20 October 2026. NCT04965493
  99. ClinicalTrials.gov. NCT05057494 (MAJIC). Registry record, API v2, accessed 21 October 2026. NCT05057494
  100. ClinicalTrials.gov. NCT05947851 (BELLWAVE-010, MK-1026-010). Registry record, API v2, accessed 21 October 2026. NCT05947851
  101. ClinicalTrials.gov. NCT06073821 (sonrotoclax plus zanubrutinib versus venetoclax plus obinutuzumab, BGB-11417-301). Registry record, API v2, accessed 21 October 2026. NCT06073821
  102. ClinicalTrials.gov. NCT06136559 (BELLWAVE-011, MK-1026-011). Registry record, API v2, accessed 21 October 2026. NCT06136559
  103. ClinicalTrials.gov. NCT06846671 (CaDAnCe-302, BGB-16673-302). Registry record, API v2, accessed 21 October 2026. NCT06846671
  104. Davids MS, Eyre TA, Woyach JA, Roeker LE, Ferrajoli A, Wang Y, et al. Fixed-duration pirtobrutinib plus venetoclax-rituximab versus venetoclax-rituximab for patients with previously treated chronic lymphocytic leukaemia or small lymphocytic lymphoma (BRUIN CLL-322): an open-label, multicentre, randomised, controlled, phase 3 trial. Lancet. 2026;408(10553):453-470. PubMedDOI
    ЦитироватьЗагрузка…
  105. Eichhorst B, Ghia P, Bosch F, Clifford R, Gregor M, Guieze R, et al. EHA Guidelines on management of chronic lymphocytic leukemia and Richter transformation. Hemasphere. 2026;10(6):e70403. PubMedDOI
    ЦитироватьЗагрузка…
  106. European Medicines Agency. Calquence: EPAR procedural steps taken and scientific information after the authorisation (archive); document read 20 October 2026. Источник
  107. European Medicines Agency. Imbruvica: EPAR procedural steps taken and scientific information after the authorisation (archive); document read 20 October 2026. Источник
  108. European Medicines Agency. Jaypirca (pirtobrutinib): EPAR page, EMEA/H/C/005863 (page updated 15 September 2026); page read 21 October 2026. Источник
  109. European Medicines Agency. Venclyxto (venetoclax): European public assessment report page, EMEA/H/C/004106; page read 20 October 2026 (documents last updated 8 July 2026). Источник
  110. European Medicines Agency. Venclyxto: EPAR procedural steps taken and scientific information after the authorisation (archive); document read 20 October 2026. Источник
  111. European Medicines Agency. Venclyxto: EPAR procedural steps taken and scientific information after the authorisation; document read 20 October 2026. Источник
  112. US Food and Drug Administration. Calquence (acalabrutinib) prescribing information, revised 02/2026, NDA 210259/S-012. Источник
  113. US Food and Drug Administration. Supplement approval letter, Calquence (acalabrutinib) capsules NDA 210259/S-012 and tablets NDA 216387/S-006, AstraZeneca; electronic signature 19 February 2026. Источник
  114. US Food and Drug Administration. Supplement approval letter, Jaypirca (pirtobrutinib) tablets, NDA 216059/S-006 (previously untreated CLL/SLL with no known 17p deletion), Loxo Oncology, Inc.; electronic signature dated 10/02/2026. Источник
  115. U.S. Food and Drug Administration. Drugs@FDA: Approval date(s) and history, BLA 103948 (Campath, Lemtrada). Accessed 20 October 2026. Источник
  116. U.S. Food and Drug Administration. Drugs@FDA: Approval date(s) and history, NDA 020038 (Fludara, fludarabine phosphate). Accessed 20 October 2026. Источник
  117. U.S. Food and Drug Administration. Drugs@FDA: Approval date(s) and history, NDA 010669 (Leukeran, chlorambucil). Accessed 20 October 2026. Источник
  118. US Food and Drug Administration. Venclexta (venetoclax) prescribing information, revised 02/2026, NDA 208573/S-031. Источник
  119. US Food and Drug Administration. Supplement approval letter, Venclexta (venetoclax), NDA 208573/S-031, AbbVie Inc.; electronic signature 19 February 2026. Источник
  120. FDA. Withdrawn | Cancer Accelerated Approvals. Listing, content current as of 5 October 2026 (accessed 19 October 2026). Источник
  121. US Food and Drug Administration. Withdrawn: Cancer Accelerated Approvals (web page listing Zydelig, Copiktra and Oforta rows). Accessed 20 October 2026. Источник
  122. Jurczak W, Kwiatek M, Czyz J, Roberto de Mattos E, Eom KS, Egle A, et al. BRUIN CLL-313: Randomized Phase III Trial of Pirtobrutinib Versus Bendamustine Plus Rituximab in Untreated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma. J Clin Oncol. 2026;44(6):466-475. PubMedDOI
    ЦитироватьЗагрузка…
  123. Kater AP, Seymour J. Beyond MURANO: sequencing therapy in relapsed chronic lymphocytic leukaemia. Lancet. 2026;408(10553):388-390. PubMedDOI
    ЦитироватьЗагрузка…
  124. National Cancer Institute, Surveillance, Epidemiology, and End Results Program. SEER Cancer Stat Facts: Chronic Lymphocytic Leukemia. Page accessed 21 October 2026; the page displays no update date (its HTML last_modified tag reads 22 April 2026). Источник
  125. Wierda WG, Brown J, Abramson JS, Awan F, Bociek G, Boyer D, et al. NCCN Guidelines® Insights: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Version 2.2026. J Natl Compr Canc Netw. 2026;24(3):68-80. PubMedDOI
    ЦитироватьЗагрузка…
  126. Yi S, Cao J, Feng R, Zhou K, Qiu L, Li F, et al. A comprehensive analysis of pirtobrutinib in Chinese patients with chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL/SLL): Results from the phase 3 study BRUIN CLL-321. Br J Haematol. 2026;208(3):926-936. PubMedDOI
    ЦитироватьЗагрузка…