TAGRISSO™ (osimertinib)

Tagrisso is geïndiceerd voor de behandeling van volwassen patiënten met lokaal gevorderde of gemetastaseerde niet-kleincellige longkanker (NSCLC) met een epidermale groeifactor receptor (EGFR) T790M-mutatie.

Referenties

  1. Samenvatting van de productkenmerken Tagrisso, meest recente versie.
  2. Gearchiveerde gegevens, 947230.011, AstraZeneca Pharmaceuticals LP.
  3. Yang J, Ramalingam S, Janne P, et al. Osimertinib (AZD9291) in pre-treated patients with T790M-positive advanced NSCLC: updated Phase l (Pl) and pooled Phase 2 (P2) results. Gepresenteerd tijdens: De Europese Longkanker Conferentie; april 2016; Genève, Zwitserland.
  4. Mok TS, Wu YL, Ahn MJ, et al. Osimertinib or platinum-pemetrexed in EGFR T790M positive lung cancer [published online ahead of print December 6, 2016]. N Engl J Med. 2016. doi:10.1056/NEJMoa1612674.
  5. Diaz LA Jr, Bardelli A. Liquid biopsies: genotyping circulating tumor DNA. J Clin Onkol. 2014;32:579-586.
  6. Jenkins S, Ramalingam S, Patel S, et al. Plasma ctDNA analysis for detection of EGFR T790M mutation in patients (pts) with EGFR mutation-positive advanced non-small cell lung cancer (aNSCLC). Gepresenteerd tijdens: De Europese Longkanker Conferentie; april 2016; Genève, Zwitserland.
  7. Schwaederle M, Husain H, Fanta PT, et al. Detection rate of actionable mutations in diverse cancers using a biopsy-free (blood) circulating tumor cell DNA assay. Oncotarget. 2016;7:9707-9717.
  8. Thress KS, Brant R, Carr TH, et al. EGFR mutation detection in ctDNA from NSCLC patient plasma: across-platform comparison of leading technologies to support the clinical development of AZD9291. Lung Cancer. 2015;90:509-515
  9. Cobas®  EGFR Mutation Test v2 [verpakkingsbijlage]. Indianapolis, IN: Roche Molecular Systems, Inc. 2016.
  10. Oxnard GR, Thress KS, Alden RS, et al. Association between plasma genotyping and outcomes of treatment with osimertinib (AZD9291) in advanced non-small-cell lung cancer. J Clin Onkol. 2016;34:3375-3382
  11. Redig AJ, Jänne PA. Basket trials and the evolution of clinical trial design in an era of genomic medicine. J Clin Onkol. 2015;33:975-978.
  12. Karlovich C, Goldman JW, Sun JM, et al. Assessment of EGFR mutation status in matched plasma and tumor tissue of NSCLC patients from a phase I study of rociletinib (CO-1686). Clin Cancer Res. 2016;22:2386-2395.
  13. Sacher AG, Paweletz C, Dahlberg SE, et al. Prospective validation of rapid plasma genotyping for the detection of EGFR and KRAS mutations in advanced lung cancer. JAMA Oncol. doi:l0.1001/jamaoncol.2016.0173.
  14. Lalkhen AG, McCluskey A. Clinical tests: sensitivity and specificity. Contin Educ Anaesth Crit Care Pain. 2008;8:221-223. doi:l0.1093/bjaceaccp/mkn04l NCCN, National Comprehensive Cancer Network.
  15. Yu HA, Arcila ME, Rekhtman N, et al. Analysis of tumor specimens at the time of acquired resistance to EGFR-TKI therapy in 155 patients with EGFR-mutant lung cancers. Clin Cancer Res. 2013;19:2240-2247. 
  16. Langer CJ. Epidermal growth factor receptor inhibition in mutation-positive non-small-cell lung cancer: is afatinib better or simply newer? J Clin Onkol. 2013;3l:3303-3306
  17. Soria JC, Wu YL, Nakagawa K, et al. Gefitinib plus chemotherapy versus placebo plus chemotherapy in EGFR-mutation-positive non-small-cell lung cancer after progression on first-line gefitinib (IMPRESS): a phase 3 randomised trial. Lancet Onkol. 2015;16:990-998.
  18. Oxnard GR, Arcila ME, Sima CS, et al. Acquired resistance to EGFR tyrosine kinase inhibitors in EGFR-mutant lung cancer: distinct natural history of patients with tumors harboring the T790M mutation. Clin Cancer Res. 2011;17:1616-1622.
  19. Arcila ME, Oxnard GR, Nafa K, et al. Rebiopsy of lung cancer patients with acquired resistance to EGFR inhibitors and enhanced detection of the T790M mutation using a locked nucleic acid-based assay. Clin Cancer Res. 2011;17:1169-1180.
  20. Sun JM, Ahn MJ, Choi YL, et al. Clinical implications of T790M mutation in patients with acquired resistance to EGFR tyrosine kinase inhibitors. Lung Cancer. 2013;82:294-298.
  21. Kuiper JL, Heideman DAM, Thunnissen E, et al. Incidence of T790M mutation in (sequential) rebiopsies in EGFR-mutated NSCLC-patients. Lung Cancer. 2014;85:19-24.
  22. Li W, Ren S, Li J, et al. T790M mutation is associated with better efficacy of treatment beyond progression with EGFR-TKI in advanced NSCLC patients. Lung Cancer. 2014;84:295-300.
  23. Cross DAE, Ashton SE, Ghiorghiu S, et al. AZD9291, an irreversible EGFR TKI, overcomes T790M-mediated resistance to EGFR inhibitors in lung cancer. Cancer Discov. 2014;4:1046-1061.
  24. Goss GD, Yang JCH, Ahn MJ, et al. AZD9291 in pre-treated patients with T790M positive advanced non-small cell lung cancer (NSCLC): pooled analysis from two phase II studies. Gepresenteerd tijdens: Het Europees Kanker Congres; september 2015; Wenen, Oostenrijk.
  25. Goss G, Tsai C, Shephard F, et al. CNS response to osimertinib in patients with T790M-positive advanced NSCLC: pooled data from phase II trials. Gepresenteerd tijdens: 17e Wereldwijde Conferentie over Longkanker; 4-7 december 2016. Wenen, Oostenrijk.
  26. Gearchiveerde gegevens, 986,561.011, AstraZeneca Pharmaceuticals LP.
  27. Mok Osimertinib AURA3. Osimertinib or Platinum-Pemetrexed in EGFR T790M Positive Lung Cancer supplementary.Final.21Oct2016

NS ID XL-0228-RD01/2018-WEB