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References: Melanoma

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

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  19. Eggermont AM, Suciu S, Santinami M, Testori A, Kruit WH, Marsden J, et al. Adjuvant therapy with pegylated interferon alfa-2b versus observation alone in resected stage III melanoma: final results of EORTC 18991, a randomised phase III trial. Lancet. 2008;372(9633):117-126. PubMedDOI
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  21. Hodi FS, O'Day SJ, McDermott DF, Weber RW, Sosman JA, Haanen JB, et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med. 2010;363(8):711-23. PubMedDOI
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  22. Mocellin S, Pasquali S, Rossi CR, Nitti D. Interferon alpha adjuvant therapy in patients with high-risk melanoma: a systematic review and meta-analysis. J Natl Cancer Inst. 2010;102(7):493-501. PubMedDOI
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  23. Chapman PB, Hauschild A, Robert C, Haanen JB, Ascierto P, Larkin J, et al. Improved survival with vemurafenib in melanoma with BRAF V600E mutation. N Engl J Med. 2011;364(26):2507-16. PubMedDOI
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  24. FDA. Supplement approval letter dated 29 March 2011, BLA 103949/5153 (peginterferon alfa-2b, marketed for this indication as Sylatron), Schering Corporation. Source
  25. U.S. Food and Drug Administration. BLA approval letter, STN BL 125377/0, YERVOY (ipilimumab). 25 March 2011. Source
  26. U.S. Food and Drug Administration. NDA approval letter, NDA 202429, Zelboraf (vemurafenib). e-signed 17 August 2011. Source
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  28. Rosenberg SA, Yang JC, Sherry RM, Kammula US, Hughes MS, Phan GQ, et al. Durable complete responses in heavily pretreated patients with metastatic melanoma using T-cell transfer immunotherapy. Clin Cancer Res. 2011;17(13):4550-7. PubMedDOI
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  29. Eggermont AM, Suciu S, Testori A, Santinami M, Kruit WH, Marsden J, et al. Long-term results of the randomized phase III trial EORTC 18991 of adjuvant therapy with pegylated interferon alfa-2b versus observation in resected stage III melanoma. J Clin Oncol. 2012;30(31):3810-8. PubMedDOI
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  30. Herndon TM, Demko SG, Jiang X, He K, Gootenberg JE, Cohen MH, et al. U.S. Food and Drug Administration Approval: peginterferon-alfa-2b for the adjuvant treatment of patients with melanoma. Oncologist. 2012;17(10):1323-8. PubMedDOI
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  31. Flaherty KT, Infante JR, Daud A, Gonzalez R, Kefford RF, Sosman J, et al. Combined BRAF and MEK inhibition in melanoma with BRAF V600 mutations. N Engl J Med. 2012;367(18):1694-703. PubMedDOI
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  32. Flaherty KT, Robert C, Hersey P, Nathan P, Garbe C, Milhem M, et al. Improved survival with MEK inhibition in BRAF-mutated melanoma. N Engl J Med. 2012;367(2):107-14. PubMedDOI
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  33. Hauschild A, Grob JJ, Demidov LV, Jouary T, Gutzmer R, Millward M, et al. Dabrafenib in BRAF-mutated metastatic melanoma: a multicentre, open-label, phase 3 randomised controlled trial. Lancet. 2012;380(9839):358-65. PubMedDOI
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  34. Rebecca VW, Sondak VK, Smalley KS. A brief history of melanoma: from mummies to mutations. Melanoma Res. 2012;22(2):114-22. PubMedDOI
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  35. Topalian SL, Hodi FS, Brahmer JR, Gettinger SN, Smith DC, McDermott DF, et al. Safety, activity, and immune correlates of anti-PD-1 antibody in cancer. N Engl J Med. 2012;366(26):2443-54. PubMedDOI
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  36. U.S. Food and Drug Administration. NDA approval letter, NDA 204114, Mekinist (trametinib). e-signed 29 May 2013. Source
  37. U.S. Food and Drug Administration. NDA approval letter, NDA 202806, Tafinlar (dabrafenib). e-signed 29 May 2013. Source
  38. Hamid O, Robert C, Daud A, Hodi FS, Hwu WJ, Kefford R, et al. Safety and tumor responses with lambrolizumab (anti-PD-1) in melanoma. N Engl J Med. 2013;369(2):134-44. PubMedDOI
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  39. U.S. Food and Drug Administration. BLA accelerated approval letter, BLA 125514/0, Keytruda (pembrolizumab). e-signed 4 September 2014. Source
  40. U.S. Food and Drug Administration. Supplement approval letter (accelerated approval), NDA 204114/S-001, Mekinist (trametinib). e-signed 8 January 2014. Source
  41. U.S. Food and Drug Administration. BLA accelerated approval letter, BLA 125554, Opdivo (nivolumab). e-signed 22 December 2014. Source
  42. U.S. Food and Drug Administration. Supplement approval letter (accelerated approval), NDA 202806/S-002, Tafinlar (dabrafenib). e-signed 9 January 2014. Source
  43. Gorantla VC, Kirkwood JM. State of melanoma: an historic overview of a field in transition. Hematol Oncol Clin North Am. 2014;28(3):415-35. PubMedDOI
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  44. Long GV, Stroyakovskiy D, Gogas H, Levchenko E, de Braud F, Larkin J, et al. Combined BRAF and MEK inhibition versus BRAF inhibition alone in melanoma. N Engl J Med. 2014;371(20):1877-88. PubMedDOI
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  45. Morton DL, Thompson JF, Cochran AJ, Mozzillo N, Nieweg OE, Roses DF, et al. Final trial report of sentinel-node biopsy versus nodal observation in melanoma. N Engl J Med. 2014;370(7):599-609. PubMedDOI
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  46. Amgen. FDA approves IMLYGIC (talimogene laherparepvec) as first oncolytic viral therapy in the US. Company press release, 27 October 2015. Source
  47. Andtbacka RH, Kaufman HL, Collichio F, Amatruda T, Senzer N, Chesney J, et al. Talimogene Laherparepvec Improves Durable Response Rate in Patients With Advanced Melanoma. J Clin Oncol. 2015;33(25):2780-8. PubMedDOI
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  48. Cancer Genome Atlas Network. Genomic Classification of Cutaneous Melanoma. Cell. 2015;161(7):1681-96. PubMedDOI
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  49. Eggermont AM, Chiarion-Sileni V, Grob JJ, Dummer R, Wolchok JD, Schmidt H, et al. Adjuvant ipilimumab versus placebo after complete resection of high-risk stage III melanoma (EORTC 18071): a randomised, double-blind, phase 3 trial. Lancet Oncol. 2015;16(5):522-30. PubMedDOI
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  50. European Medicines Agency. Imlygic (talimogene laherparepvec): EPAR page; marketing authorisation issued 16 December 2015. Source
  51. U.S. Food and Drug Administration. NDA approval letter (replacement letter), NDA 206192, Cotellic (cobimetinib). The letter states that the effective approval date remains 10 November 2015. Source
  52. US Food and Drug Administration, CBER. BLA approval letter, STN 125518/0, IMLYGIC (talimogene laherparepvec), Amgen, Inc.; dated 27 October 2015. Internet Archive capture (11 January 2017) of the document linked from the FDA product page as 'October 27, 2015 Approval Letter - IMLYGIC'. Source
  53. US Food and Drug Administration, CBER. IMLYGIC (talimogene laherparepvec) BLA 125518: approval history, letters, reviews and related documents (review memoranda dated October 2015, including Bryan WW, 23 October 2015, and O'Leary MC, 8 October 2015). Source
  54. US Food and Drug Administration, CBER. Summary Basis for Regulatory Action, BLA STN 125518/0, IMLYGIC (talimogene laherparepvec); dated 27 October 2015. Internet Archive capture (11 January 2017) of the document linked from the FDA product page. Source
  55. U.S. Food and Drug Administration. Supplement approval letter (fulfillment of postmarketing requirement), BLA 125514/S-4 and S-6, Keytruda (pembrolizumab). e-signed 18 December 2015. Source
  56. U.S. Food and Drug Administration. Supplement approval letter, BLA 125554/S-001, Opdivo (nivolumab). e-signed 23 November 2015. Source
  57. U.S. Food and Drug Administration. Supplement accelerated approval letter, BLA 125554/S-002, Opdivo (nivolumab) in combination with ipilimumab. e-signed 30 September 2015. Source
  58. U.S. Food and Drug Administration. Supplement approval letter (fulfillment of postmarketing requirement), NDA 202806/S-004, Tafinlar (dabrafenib). e-signed 20 November 2015. Source
  59. FDA. Supplement approval letter, BLA 125377/S-073 (Yervoy, ipilimumab), Bristol-Myers Squibb Company; signed 28 October 2015. Source
  60. Larkin J, Chiarion-Sileni V, Gonzalez R, Grob JJ, Cowey CL, Lao CD, et al. Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma. N Engl J Med. 2015;373(1):23-34. PubMedDOI
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  61. Long GV, Stroyakovskiy D, Gogas H, Levchenko E, de Braud F, Larkin J, et al. Dabrafenib and trametinib versus dabrafenib and placebo for Val600 BRAF-mutant melanoma: a multicentre, double-blind, phase 3 randomised controlled trial. Lancet. 2015;386(9992):444-51. PubMedDOI
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  62. Postow MA, Chesney J, Pavlick AC, Robert C, Grossmann K, McDermott D, et al. Nivolumab and ipilimumab versus ipilimumab in untreated melanoma. N Engl J Med. 2015;372(21):2006-17. PubMedDOI
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  63. Ribas A, Puzanov I, Dummer R, Schadendorf D, Hamid O, Robert C, et al. Pembrolizumab versus investigator-choice chemotherapy for ipilimumab-refractory melanoma (KEYNOTE-002): a randomised, controlled, phase 2 trial. Lancet Oncol. 2015;16(8):908-18. PubMedDOI
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  64. Robert C, Long GV, Brady B, Dutriaux C, Maio M, Mortier L, et al. Nivolumab in previously untreated melanoma without BRAF mutation. N Engl J Med. 2015;372(4):320-30. PubMedDOI
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  65. Robert C, Karaszewska B, Schachter J, Rutkowski P, Mackiewicz A, Stroiakovski D, et al. Improved overall survival in melanoma with combined dabrafenib and trametinib. N Engl J Med. 2015;372(1):30-9. PubMedDOI
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  66. Robert C, Schachter J, Long GV, Arance A, Grob JJ, Mortier L, et al. Pembrolizumab versus Ipilimumab in Advanced Melanoma. N Engl J Med. 2015;372(26):2521-32. PubMedDOI
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  67. Schadendorf D, Hodi FS, Robert C, Weber JS, Margolin K, Hamid O, et al. Pooled Analysis of Long-Term Survival Data From Phase II and Phase III Trials of Ipilimumab in Unresectable or Metastatic Melanoma. J Clin Oncol. 2015;33(17):1889-94. PubMedDOI
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  68. Weber JS, D'Angelo SP, Minor D, Hodi FS, Gutzmer R, Neyns B, et al. Nivolumab versus chemotherapy in patients with advanced melanoma who progressed after anti-CTLA-4 treatment (CheckMate 037): a randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2015;16(4):375-84. PubMedDOI
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  69. Eggermont AM, Chiarion-Sileni V, Grob JJ, Dummer R, Wolchok JD, Schmidt H, et al. Prolonged Survival in Stage III Melanoma with Ipilimumab Adjuvant Therapy. N Engl J Med. 2016;375(19):1845-1855. PubMedDOI
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  70. U.S. Food and Drug Administration. Supplement approval letter, BLA 125554/S-007, Opdivo (nivolumab). e-signed 23 January 2016. Source
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  72. Leiter U, Stadler R, Mauch C, Hohenberger W, Brockmeyer N, Berking C, et al. Complete lymph node dissection versus no dissection in patients with sentinel lymph node biopsy positive melanoma (DeCOG-SLT): a multicentre, randomised, phase 3 trial. Lancet Oncol. 2016;17(6):757-767. PubMedDOI
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  73. Faries MB, Thompson JF, Cochran AJ, Andtbacka RH, Mozzillo N, Zager JS, et al. Completion Dissection or Observation for Sentinel-Node Metastasis in Melanoma. N Engl J Med. 2017;376(23):2211-2222. PubMedDOI
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  74. FDA. Supplement approval letter, BLA 125554/S-055 (Opdivo, nivolumab), Bristol-Myers Squibb Company; signed 20 December 2017. Source
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  83. U.S. Food and Drug Administration. NDA approval letter, NDA 210496, Braftovi (encorafenib). e-signed 27 June 2018. Source
  84. U.S. Food and Drug Administration. NDA approval letter, NDA 210498, Mektovi (binimetinib). e-signed 27 June 2018. Source
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  89. FDA. Supplement approval letter, BLA 125514/S-40 (Keytruda, pembrolizumab), Merck Sharp & Dohme Corp.; signed 15 February 2019. Source
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  98. FDA. Supplement approval letter, BLA 125514/S-112 (Keytruda, pembrolizumab), Merck Sharp and Dohme Corporation; signed 3 December 2021. Source
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  101. European Medicines Agency. Kimmtrak (tebentafusp): EPAR page; opinion adopted 27 January 2022, marketing authorisation issued 1 April 2022. Source
  102. US Food and Drug Administration. BLA approval letter, BLA 761228, KIMMTRAK (tebentafusp-tebn), Immunocore Limited; signed 25 January 2022. Source
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