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References: Lung cancer

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

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  17. US Food and Drug Administration. Supplement approval letter (revised labeling reflecting Trial 709, Iressa Access Program), Iressa (gefitinib) tablets, NDA 21-399/S-008, AstraZeneca Pharmaceuticals LP; signed 17 June 2005. Source
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  26. US Food and Drug Administration. Accelerated approval letter, Xalkori (crizotinib), NDA 202570, Pfizer Inc.; electronic signature date 26 August 2011. Source
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  34. Borghaei H, Paz-Ares L, Horn L, Spigel DR, Steins M, Ready NE, et al. Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer. N Engl J Med. 2015;373(17):1627-39. PubMedDOI
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  36. Chang JY, Senan S, Paul MA, Mehran RJ, Louie AV, Balter P, et al. Stereotactic ablative radiotherapy versus lobectomy for operable stage I non-small-cell lung cancer: a pooled analysis of two randomised trials. Lancet Oncol. 2015;16(6):630-7. PubMedDOI
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  37. FDA. Approval letter, BLA 125527 (Opdivo, nivolumab), signed 4 March 2015. Source
  38. FDA. Approval letter, BLA 125554/S-005 (Opdivo, nivolumab), signed 9 October 2015. Source
  39. FDA. Approval letter, BLA 125514/S-5 (Keytruda, pembrolizumab), signed 2 October 2015. Source
  40. US Food and Drug Administration. NDA approval letter, Iressa (gefitinib) 250 mg tablets, NDA 206995, AstraZeneca UK Limited; signed 13 July 2015. Source
  41. US Food and Drug Administration, Center for Drug Evaluation and Research. Division Director Summary Review, NDA 206995 (Iressa, gefitinib), Reference ID 3791519; approval 13 July 2015. Source
  42. FDA. Approval letter, BLA 761041 (Tecentriq, atezolizumab), signed 18 October 2016. Source
  43. FDA. Approval letter, BLA 125514/S-8 and S-12 (Keytruda, pembrolizumab), signed 24 October 2016. Source
  44. US Food and Drug Administration. Supplement approval letter, Xalkori (crizotinib), NDA 202570/S-016, Pfizer, Inc.; signed 11 March 2016. Source
  45. Herbst RS, Baas P, Kim DW, Felip E, Pérez-Gracia JL, Han JY, et al. Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial. Lancet. 2016;387(10027):1540-1550. PubMedDOI
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  46. Langer CJ, Gadgeel SM, Borghaei H, Papadimitrakopoulou VA, Patnaik A, Powell SF, et al. Carboplatin and pemetrexed with or without pembrolizumab for advanced, non-squamous non-small-cell lung cancer: a randomised, phase 2 cohort of the open-label KEYNOTE-021 study. Lancet Oncol. 2016;17(11):1497-1508. PubMedDOI
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  47. Reck M, Rodríguez-Abreu D, Robinson AG, Hui R, Csőszi T, Fülöp A, et al. Pembrolizumab versus Chemotherapy for PD-L1-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2016;375(19):1823-1833. PubMedDOI
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  48. Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, et al. Durvalumab after Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. N Engl J Med. 2017;377(20):1919-1929. PubMedDOI
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  49. Carbone DP, Reck M, Paz-Ares L, Creelan B, Horn L, Steins M, et al. First-Line Nivolumab in Stage IV or Recurrent Non-Small-Cell Lung Cancer. N Engl J Med. 2017;376(25):2415-2426. PubMedDOI
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  50. Faivre-Finn C, Snee M, Ashcroft L, Appel W, Barlesi F, Bhatnagar A, et al. Concurrent once-daily versus twice-daily chemoradiotherapy in patients with limited-stage small-cell lung cancer (CONVERT): an open-label, phase 3, randomised, superiority trial. Lancet Oncol. 2017;18(8):1116-1125. PubMedDOI
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  51. FDA. Approval letter, BLA 125514/S-16 (Keytruda, pembrolizumab), signed 10 May 2017. Source
  52. US Food and Drug Administration. Supplement approval letter (fulfilment of postmarketing requirement), Alecensa (alectinib), NDA 208434/S-03, Hoffmann-La Roche; electronic signature date 6 November 2017. Source
  53. Peters S, Camidge DR, Shaw AT, Gadgeel S, Ahn JS, Kim DW, et al. Alectinib versus Crizotinib in Untreated ALK-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2017;377(9):829-838. PubMedDOI
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  54. Rittmeyer A, Barlesi F, Waterkamp D, Park K, Ciardiello F, von Pawel J, et al. Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial. Lancet. 2017;389(10066):255-265. PubMedDOI
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  55. Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, et al. Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC. N Engl J Med. 2018;379(24):2342-2350. PubMedDOI
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  56. FDA. Approval letter, BLA 761069/S-002 (Imfinzi, durvalumab), signed 16 February 2018. Source
  57. FDA. Approval letter, BLA 125514/S-035 (Keytruda, pembrolizumab), signed 20 August 2018. Source
  58. FDA. Approval letter, BLA 125514/S-41 (Keytruda, pembrolizumab), signed 30 October 2018. Source
  59. US Food and Drug Administration. Accelerated approval letter, Lorbrena (lorlatinib), NDA 210868, Pfizer Inc.; electronic signature date 2 November 2018. Source
  60. US Food and Drug Administration. Supplement approval letter, Tagrisso (osimertinib), NDA 208065/S-008, AstraZeneca Pharmaceuticals LP; electronic signature date 18 April 2018. Source
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  62. Horn L, Mansfield AS, Szczęsna A, Havel L, Krzakowski M, Hochmair MJ, et al. First-Line Atezolizumab plus Chemotherapy in Extensive-Stage Small-Cell Lung Cancer. N Engl J Med. 2018;379(23):2220-2229. PubMedDOI
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  63. Paz-Ares L, Luft A, Vicente D, Tafreshi A, Gümüş M, Mazières J, et al. Pembrolizumab plus Chemotherapy for Squamous Non-Small-Cell Lung Cancer. N Engl J Med. 2018;379(21):2040-2051. PubMedDOI
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  64. Soria JC, Ohe Y, Vansteenkiste J, Reungwetwattana T, Chewaskulyong B, Lee KH, et al. Osimertinib in Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer. N Engl J Med. 2018;378(2):113-125. PubMedDOI
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  65. FDA. Replacement approval letter, BLA 125514/S-47 (Keytruda, pembrolizumab; first-line single agent, PD-L1 TPS 1% or higher, NSCLC), stating that the effective approval date remains 11 April 2019. Source
  66. US Food and Drug Administration. NDA approval letter, Rozlytrek (entrectinib) capsules, NDA 212725, Genentech, Inc.; signed 15 August 2019. Source
  67. FDA. Supplement approval letter, BLA 761034/S-019 (Tecentriq, atezolizumab; with carboplatin and etoposide, first-line extensive-stage small cell lung cancer), electronic signature 18 March 2019. Source
  68. Paz-Ares L, Dvorkin M, Chen Y, Reinmuth N, Hotta K, Trukhin D, et al. Durvalumab plus platinum-etoposide versus platinum-etoposide in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): a randomised, controlled, open-label, phase 3 trial. Lancet. 2019;394(10212):1929-1939. PubMedDOI
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  69. Reck M, Rodríguez-Abreu D, Robinson AG, Hui R, Csőszi T, Fülöp A, et al. Updated Analysis of KEYNOTE-024: Pembrolizumab Versus Platinum-Based Chemotherapy for Advanced Non-Small-Cell Lung Cancer With PD-L1 Tumor Proportion Score of 50% or Greater. J Clin Oncol. 2019;37(7):537-546. PubMedDOI
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  70. de Koning HJ, van der Aalst CM, de Jong PA, Scholten ET, Nackaerts K, Heuvelmans MA, et al. Reduced Lung-Cancer Mortality with Volume CT Screening in a Randomized Trial. N Engl J Med. 2020;382(6):503-513. PubMedDOI
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  71. Drilon A, Siena S, Dziadziuszko R, Barlesi F, Krebs MG, Shaw AT, et al. Entrectinib in ROS1 fusion-positive non-small-cell lung cancer: integrated analysis of three phase 1-2 trials. Lancet Oncol. 2020;21(2):261-270. PubMedDOI
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  73. FDA. Approval letter, BLA 125554/S-80 (Opdivo, nivolumab with ipilimumab; first-line metastatic or recurrent NSCLC, PD-L1 1% or higher), signed 15 May 2020. Source
  74. US Food and Drug Administration. Accelerated approval letter, Gavreto (pralsetinib) capsules, NDA 213721, Blueprint Medicines Corporation; signed 4 September 2020. Source
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  76. US Food and Drug Administration. Accelerated approval letter, Retevmo (selpercatinib) capsules, NDA 213246, Loxo Oncology Inc.; signed 8 May 2020. Source
  77. US Food and Drug Administration. Accelerated approval letter, Tabrecta (capmatinib) tablets, NDA 213591, Novartis Pharmaceuticals Corporation; signed 6 May 2020. Source
  78. US Food and Drug Administration. Supplement approval letter, Tagrisso (osimertinib), NDA 208065/S-021, AstraZeneca; electronic signature date 18 December 2020. Source
  79. FDA. Accelerated approval letter, NDA 213702 (Zepzelca, lurbinectedin; metastatic small cell lung cancer with disease progression on or after prior platinum-based chemotherapy), electronic signature 15 June 2020. Source
  80. Gadgeel S, Rodríguez-Abreu D, Speranza G, Esteban E, Felip E, Dómine M, et al. Updated Analysis From KEYNOTE-189: Pembrolizumab or Placebo Plus Pemetrexed and Platinum for Previously Untreated Metastatic Nonsquamous Non-Small-Cell Lung Cancer. J Clin Oncol. 2020;38(14):1505-1517. PubMedDOI
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  82. Paik PK, Felip E, Veillon R, Sakai H, Cortot AB, Garassino MC, et al. Tepotinib in Non-Small-Cell Lung Cancer with MET Exon 14 Skipping Mutations. N Engl J Med. 2020;383(10):931-943. PubMedDOI
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  83. Ramalingam SS, Vansteenkiste J, Planchard D, Cho BC, Gray JE, Ohe Y, et al. Overall Survival with Osimertinib in Untreated, EGFR-Mutated Advanced NSCLC. N Engl J Med. 2020;382(1):41-50. PubMedDOI
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  84. Rudin CM, Awad MM, Navarro A, Gottfried M, Peters S, Csőszi T, et al. Pembrolizumab or Placebo Plus Etoposide and Platinum as First-Line Therapy for Extensive-Stage Small-Cell Lung Cancer: Randomized, Double-Blind, Phase III KEYNOTE-604 Study. J Clin Oncol. 2020;38(21):2369-2379. PubMedDOI
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  85. Shaw AT, Bauer TM, de Marinis F, Felip E, Goto Y, Liu G, et al. First-Line Lorlatinib or Crizotinib in Advanced ALK-Positive Lung Cancer. N Engl J Med. 2020;383(21):2018-2029. PubMedDOI
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  90. FDA. Corrected supplement approval letter, BLA 761034/S-042 (Tecentriq, atezolizumab), electronically signed 20 October 2021; states that the effective action date remains 15 October 2021, the date of the original letter. Source
  91. FDA. Approval letter, BLA 761097/S-7 (Libtayo, cemiplimab-rwlc; first-line NSCLC with PD-L1 TPS 50% or higher), signed 22 February 2021. Source
  92. US Food and Drug Administration. Supplement approval letter (fulfilment of postmarketing requirement), Lorbrena (lorlatinib), NDA 210868/S-004, Pfizer Inc.; electronic signature date 3 March 2021. Source
  93. US Food and Drug Administration. Accelerated approval letter, Lumakras (sotorasib) tablets, NDA 214665, Amgen Inc.; signed 28 May 2021. Source
  94. US Food and Drug Administration. BLA accelerated approval letter, Rybrevant (amivantamab-vmjw) injection, BLA 761210, Janssen Biotech, Inc.; signed 21 May 2021. Source
  95. US Food and Drug Administration. Accelerated approval letter, Tepmetko (tepotinib) tablets, NDA 214096, EMD Serono Inc.; signed 3 February 2021. Source
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  98. Goldman JW, Dvorkin M, Chen Y, Reinmuth N, Hotta K, Trukhin D, et al. Durvalumab, with or without tremelimumab, plus platinum-etoposide versus platinum-etoposide alone in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): updated results from a randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2021;22(1):51-65. PubMedDOI
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  99. Krist AH, Davidson KW, Mangione CM, Barry MJ, Cabana M, Caughey AB, et al. Screening for Lung Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2021;325(10):962-970. PubMedDOI
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  102. FDA. Approval letter, BLA 761097/S-14 (Libtayo, cemiplimab-rwlc with platinum-based chemotherapy; first-line NSCLC), signed 8 November 2022. Source
  103. FDA. Approval letter, BLA 761069/S-33 (Imfinzi, durvalumab with tremelimumab-actl and platinum-based chemotherapy; metastatic NSCLC), signed 10 November 2022. Source
  104. FDA. Approval letter, BLA 125554/S-112 (Opdivo, nivolumab), signed 4 March 2022. Source
  105. US Food and Drug Administration. Accelerated approval supplement letter, Enhertu (fam-trastuzumab deruxtecan-nxki), BLA 761139/S-021, Daiichi Sankyo, Inc.; signed 11 August 2022. Source
  106. US Food and Drug Administration. Accelerated approval letter, Krazati (adagrasib) oral tablets, NDA 216340, Mirati Therapeutics, Inc.; signed 12 December 2022. Source
  107. US Food and Drug Administration. Supplement approval and fulfilment of postmarketing requirements letter, Retevmo (selpercatinib) capsules, NDA 213246/S-007, Loxo Oncology Inc.; signed 21 September 2022. Source
  108. US Food and Drug Administration. Supplement approval and fulfilment of postmarketing requirement letter, Tabrecta (capmatinib) tablets, NDA 213591/S-004, Novartis Pharmaceuticals Corporation; signed 10 August 2022. Source
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