Osimertinib: First Global Approval.

作者: Sarah L. Greig

DOI: 10.1007/S40265-015-0533-4

关键词:

摘要: Osimertinib (Tagrisso™, AZD9291) is an oral, third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) that being developed by AstraZeneca for the treatment of advanced non-small cell lung cancer (NSCLC). has been designed to target EGFR T790M mutation often present in NSCLC patients with acquired TKI resistance, while sparing wild-type EGFR. In November 2015, tablet formulation osimertinib was granted accelerated approval USA metastatic mutation-positive (as detected FDA-approved test) who have progressed on or after therapy. also assessment status this indication EU, and phase III development first- second-line adjuvant several countries. Phase I trials solid tumours are conducted. This article summarizes milestones leading first NSCLC.

参考文章(24)
Kenneth S Thress, Cloud P Paweletz, Enriqueta Felip, Byoung Chul Cho, Daniel Stetson, Brian Dougherty, Zhongwu Lai, Aleksandra Markovets, Ana Vivancos, Yanan Kuang, Dalia Ercan, Sarah E Matthews, Mireille Cantarini, J Carl Barrett, Pasi A Jänne, Geoffrey R Oxnard, Acquired EGFR C797S mutation mediates resistance to AZD9291 in non–small cell lung cancer harboring EGFR T790M Nature Medicine. ,vol. 21, pp. 560- 562 ,(2015) , 10.1038/NM.3854
D. Planchard, Y. Loriot, F. André, A. Gobert, N. Auger, L. Lacroix, J.C. Soria, EGFR-independent mechanisms of acquired resistance to AZD9291 in EGFR T790M-positive NSCLC patients Annals of Oncology. ,vol. 26, pp. 2073- 2078 ,(2015) , 10.1093/ANNONC/MDV319
D. Cross, C. D'Cruz, C. Eberlein, P. Spitzler, E. Ichihara, C. Meador, S. Ashton, M. Mellor, R. Stewart, P. Smith, A. Schuller, M. Frigault, W. Pao, P.J. Jewsbury, 466PTARGETING RESISTANCE IN EGFR-MUTANT NON-SMALL CELL LUNG CANCER (NSCLC): PRECLINICAL EVIDENCE SUPPORTING THE COMBINATION OF EGFR TYROSINE KINASE INHIBITORS (TKIS) AZD9291 AND GEFITINIB WITH MOLECULARLY TARGETED AGENTS AND IMMUNOTHERAPEUTICS Annals of Oncology. ,vol. 25, ,(2014) , 10.1093/ANNONC/MDU331.26
P.A. Jänne, M.-J. Ahn, D.-W. Kim, S.-W. Kim, D. Planchard, S.S. Ramalingam, P. Frewer, M. Cantarini, S. Ghiorghiu, J.C.-H. Yang, LBA3A PHASE I STUDY OF AZD9291 IN PATIENTS WITH EGFR-TKI-RESISTANT ADVANCED NSCLC – UPDATED PROGRESSION FREE SURVIVAL AND DURATION OF RESPONSE DATA Annals of Oncology. ,vol. 26, ,(2015) , 10.1093/ANNONC/MDV128.05
Pasi A. Jänne, James Chih-Hsin Yang, Dong-Wan Kim, David Planchard, Yuichiro Ohe, Suresh S. Ramalingam, Myung-Ju Ahn, Sang-We Kim, Wu-Chou Su, Leora Horn, Daniel Haggstrom, Enriqueta Felip, Joo-Hang Kim, Paul Frewer, Mireille Cantarini, Kathryn H. Brown, Paul A. Dickinson, Serban Ghiorghiu, Malcolm Ranson, AZD9291 in EGFR Inhibitor–Resistant Non–Small-Cell Lung Cancer The New England Journal of Medicine. ,vol. 372, pp. 1689- 1699 ,(2015) , 10.1056/NEJMOA1411817
Darren A.E. Cross, Susan E. Ashton, Serban Ghiorghiu, Cath Eberlein, Caroline A. Nebhan, Paula J. Spitzler, Jonathon P. Orme, M. Raymond V. Finlay, Richard A. Ward, Martine J. Mellor, Gareth Hughes, Amar Rahi, Vivien N. Jacobs, Monica Red Brewer, Eiki Ichihara, Jing Sun, Hailing Jin, Peter Ballard, Katherine Al-Kadhimi, Rachel Rowlinson, Teresa Klinowska, Graham H.P. Richmond, Mireille Cantarini, Dong-Wan Kim, Malcolm R. Ranson, William Pao, AZD9291, an irreversible EGFR TKI, overcomes T790M-mediated resistance to EGFR inhibitors in lung cancer Cancer Discovery. ,vol. 4, pp. 1046- 1061 ,(2014) , 10.1158/2159-8290.CD-14-0337
Chee-Seng Tan, David Gilligan, Simon Pacey, Treatment approaches for EGFR-inhibitor-resistant patients with non-small-cell lung cancer Lancet Oncology. ,vol. 16, ,(2015) , 10.1016/S1470-2045(15)00246-6
K. Thress, J.C. Yang, M. Ahn, D. Kim, S. Kim, Y. Ohe, D. Planchard, R. Brant, H. Carr, S. Dearden, S. Jenkins, M. Cantarini, S. Ghiorghiu, J.C. Barrett, P.A. Janne, G.R. Oxnard, Levels of Egfr T790M in Plasma Dna As a Predictive Biomarker for Response to Azd9291, a Mutant-Selective Egfr Kinase Inhibitor Annals of Oncology. ,vol. 25, pp. iv446- ,(2014) , 10.1093/ANNONC/MDU349.49