Osimertinib: First Global Approval

Liao BC, Lin CC, Yang JC. Second and third-generation epidermal growth factor receptor tyrosine kinase inhibitors in advanced nonsmall cell lung cancer. Curr Opin Oncol. 2015;27(2):94–101.

Peters S, Zimmermann S, Adjei AA. Oral epidermal growth factor receptor tyrosine kinase inhibitors for the treatment of non-small cell lung cancer: comparative pharmacokinetics and drug-drug interactions. Cancer Treat Rev. 2014;40(8):917–26.

Tan CS, Gilligan D, Pacey S. Treatment approaches for EGFR-inhibitor-resistant patients with non-small-cell lung cancer. Lancet Oncol. 2015;16(9):e447–59.

AstraZeneca Pharmaceuticals LP. Tagrisso™ (osimertinib) tablet, for oral use: US prescribing information. 2015. http://www.fda.gov . Accessed 10 Dec 2015.

US Food and Drug Administration. FDA approves new pill to treat certain patients with non-small cell lung cancer [media release]. http://www.fda.gov . Accessed 13 Nov 2015.

AstraZeneca. Tagrisso™ (AZD9291) approved by the US FDA for patients with EGFR T790M mutation-positive metastatic non-small cell lung cancer [media release]. http://www.astrazeneca.com . Accessed 13 Nov 2015.

AstraZeneca. AstraZeneca annual report and form 20-F information 2014. 2014. http://www.astrazeneca.com . Accessed 10 Dec 2015.

Business Wire. AstraZeneca presents further evidence for the potential of AZD9291 in first-Line and pre-treated non-small cell lung cancer [media release]. http://www.businesswire.com . Accessed 8 Sep 2015.

European Medicines Agency. Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures. 2015. http://www.ema.europa.eu . Accessed 10 Dec 2015.

Lane EJ. AstraZeneca stands out again in China, hails AZD9291 in Japan [media release]. http://www.fiercepharmaasia.com . Accessed 5 Aug 2015.

AstraZeneca, MedImmune. AstraZeneca strengthens partnership with the University of Cambridge [media release]. http://www.astrazeneca.com . Accessed 16 Oct 2014.

AstraZeneca. AstraZeneca and Lilly expand immuno-oncology research collaboration with new combinations [media release]. http://www.astrazeneca.com . Accessed 22 Oct 2015.

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(9):1046–61.

Thress KS, Paweletz CP, Felip E, et al. Acquired EGFR C797S mutation mediates resistance to AZD9291 in non-small cell lung cancer harboring EGFR T790M. Nat Med. 2015;21(6):560–2.

Planchard D, Loriot Y, Andre F, et al. EGFR-independent mechanisms of acquired resistance to AZD9291 in EGFR T790M-positive NSCLC patients. Ann Oncol. 2015;26(10):2073–8.

Kim TM, Song A, Kim DW, et al. Mechanisms of acquired resistance to AZD9291, a mutation-selective, irreversible EGFR inhibitor. J Thorac Oncol. 2015. doi: 10.1097/JTO.0000000000000688 .

Cross D, D’Cruz C, Eberlein C, et al. Targeting 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 [abstract no. 466P plus poster]. Ann Oncol. 2014;25(Suppl 4):iv155.

Thress KS, Yang JC-H, Ahn M-J, et al. Levels of EGFR T790M in plasma DNA as a predictive biomarker for response to AZD9291, a mutant-selective EGFR kinase inhibitor [abstract no. 1270P plus poster]. Ann Oncol. 2014;25(Suppl 4):iv446–7.

Thress K, Leeson J, Geradts J, et al. Design, execution, and preliminary biomarker results from paired tumor biopsy cohorts of the AZD9291 AURA trial [abstract no. MINI16.09]. J Thorac Oncol. 2015;10(9 Suppl 2):S320.

Goss GD, Yang JCH, Ahn M, et al. AZD9291 in pre-treated patients with T790M positive advanced non-small cell lung cancer (NSCLC): pooled analysis from two phase II studies [abstract no. 3113 plus poster]. In: European Cancer Congress; 2015.

Planchard D, Dickinson PA, Brown KH, et al. Preliminary AZD9291 Western and Asian clinical pharmacokinetics (PK) in patients (pts) and healthy volunteers (HV): implications for formulation, dose and dosing frequency in pivotal clinical studies [abstract no. 464P plus poster]. Ann Oncol. 2014;25(Suppl 4):iv154–5.

Vishwanathan K, Dickinson PA, Bui K, et al. Effect of food and gastric pH modifiers on the pharmacokinetics of AZD9291 [abstract no. B153]. In: AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics; 2015.

Jänne PA, Yang JC, Kim DW, et al. AZD9291 in EGFR inhibitor-resistant non-small-cell lung cancer. N Engl J Med. 2015;372(18):1689–99.

Kim D, Yang J, Cross D, et al. Preclinical evidence and clinical cases of AZD9291 activity in EGFR-mutant non-small cell lung cancer (NSCLC) brain metastases (BM) [abstract no. 456P plus poster]. Ann Oncol. 2014;25(Suppl 4):iv152.

Ahn MJ, Tsai CM, Yang JCH, et al. AZD9291 activity in patients with EGFR-mutant advanced non-small cell lung cancer (NSCLC) and brain metastases: data from phase II studies [abstract no. 3083 plus poster]. In: European Cancer Congress; 2015.

Jänne PA, Ahn M-J, Kim D-W, et al. A phase I study of AZD9291 in patients with EGFR-TKI-resistant advanced NSCLC—updated progression free survival and duration of response data [abstract no. LBA3]. Ann Oncol. 2015;26(Suppl 1):i60.

Yang JC, Ahn M, Ramalingam SS, et al. AZD9291 in pre-treated T790M positive advanced NSCLC: AURA study phase II extension cohort [abstract no. MINI16.06]. J Thorac Oncol. 2015;10(9 Suppl 2):S319.

Mitsudomi T, Tsai C, Shepherd F, et al. AZD9291 in pre-treated T790M positive advanced NSCLC: AURA2 phase II study [abstract no. MINI16.08]. J Thorac Oncol. 2015;10(9 Suppl 2):S320.

Ryden A, Braam L, Martin M, et al. Patient experience of symptoms and side effects when treated with AZD9291 for advanced non-small-cell lung cancer: a qualitative interview sub-study [abstract no. 1551 plus poster]. In: European Cancer Congress; 2015.

Ryden A, Lawrance R, Papadakis K, et al. Patient-reported symptom response and impact of treatment with AZD9291 for advanced non-small-cell lung cancer [abstract no. 3030 plus poster]. In: European Cancer Congress; 2015.

Lee DH, Kim D-W, Ahn M-J, et al. AZD9291 activity in patients with leptomeningeal disease from non-small cell lung cancer: a phase I study [abstract no. PR07]. In: AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics; 2015.

Hochmair M, Holzer S, Setinek U, et al. EGFR resistant T790M mutation in NSCLC: real-life data of patients treated with AZD9291 [abstract no. P49]. Wien Klin Wochenschr. 2015;127(19–20):831.

Ramalingam SS, Yang JCH, Lee CK, et al. AZD9291, a mutant-selective EGFR inhibitor, as first-line treatment for EGFR mutation-positive advanced non-small cell lung cancer (NSCLC): results from a phase 1 expansion cohort [abstract no. 8000]. J Clin Oncol. 2015;33(15 Suppl).

Ramalingam SS, Yang J-H, Lee C, et al. AZD9291 in treatment-naive EGFRm advanced NSCLC: AURA first-line cohort [abstract no. MINI16.07]. J Thorac Oncol. 2015;10(9):S319–20.

Oxnard GR, Ramalingam SS, Ahn MJ, et al. Preliminary results of TATTON, a multi-arm phase Ib trial of AZD9291 combined with MEDI4736, AZD6094 or selumetinib in EGFR-mutant lung cancer [abstract no. 2509]. J Clin Oncol. 2015;33(15 Suppl).

Bloomberg Business. AstraZeneca temporarily halts cancer drug combination trials [media release]. http://www.bloomberg.com . Accessed 9 Oct 2015.

AstraZeneca. AstraZeneca and Roche announce partnership to develop companion diagnostic test for AZD9291 [media release]. http://www.astrazeneca.com . Accessed 28 Jul 2014.

Roche. Roche submits filing to FDA for companion diagnostic for non-small cell lung cancer drug therapy [media release]. http://www.roche.com . Accessed 30 Jul 2015.

Wu Y-L, Papadimitrakopoulou VA, Ghiorghiu S, et al. AURA3 design: a randomised, phase III study of AZD9291 versus second-line chemotherapy for patients (pts) with EGFR-TKI-resistant (T790M) advanced non-small cell lung cancer [abstract no. 140TiP]. Ann Oncol. 2015;26(Suppl 1):i43.

Ramalingam SS, Rukazenkov Y, Thomas K, et al. A randomized, phase III study (FLAURA) of AZD9291, a novel EGFR-TKI, versus gefitinib or erlotinib in treatment-naive patients with advanced non-small cell lung cancer and an EGFR-TKI-sensitizing mutation [abstract no. TPS8102]. J Clin Oncol. 2015;33(15 Suppl).