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  • AstraZeneca
  • Osimertinib is an oral, third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) drug developed by AstraZeneca Pharmaceuticals. (drugbank.ca)
  • Findings from the two studies were the basis for a new drug application for osimertinib, which was submitted to the FDA earlier this year and granted a priority review designation, according to AstraZeneca, the drug's developer. (targetedonc.com)
  • Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: "We continue to move at an unprecedented pace with osimertinib, with the full approval in Japan following closely the recent US and EU approvals. (astrazeneca.se)
  • AstraZeneca has collaborated with Roche to develop the cobas ® EGFR Mutation Test v2 as the companion diagnostic for osimertinib. (astrazeneca.se)
  • Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: "Osimertinib defines a new generation of targeted EGFR-TKI treatments, and the European Commission's expedited approval reflects the importance of this innovative medicine for addressing the needs of patients with lung cancer who have the T790M mutation. (astrazeneca.se)
  • FLAURA
  • Results of the Phase III FLAURA trial were included at the Presidential Symposium I of the European Society of Medical Oncology (ESMO) 2017 Congress in Madrid, Spain, and demonstrate a superior, clinically-meaningful progression-free survival (PFS) with osimertinib compared to current SoC EGFR tyrosine kinase inhibitors (TKIs) (erlotinib or gefitinib). (astrazeneca-us.com)
  • The FLAURA safety data for osimertinib was in line with that observed in prior clinical trials, with a low rate of Grade ≥3 adverse events (AEs). (astrazeneca-us.com)
  • median
  • At median follow-up of 16.6 months, the overall response rate (ORR) was 67% (95% CI, 47-83) for patients assigned to 80 mg once daily osimertinib and 87% (95% CI, 69-96) for patients assigned to 160 mg groups. (onclive.com)
  • A preliminary study in 60 treatment naive patients with EGFR mutations found that the median progression-free survival with osimertinib was 20.5 months, which was almost two-fold higher than results achieved with erlotinib or gefitinib. (eurekalert.org)
  • The median duration of response was two-fold higher for patients treated with osimertinib (17.2 months) versus standard of care (8.5 months). (eurekalert.org)
  • Commenting on the results for ESMO, Dr Enriqueta Felip, Head, Thoracic and H&N Cancer Group, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain, said: "Osimertinib reduced the risk of cancer progression by 54% compared with standard of care and extended the median time to progression by about nine months. (eurekalert.org)
  • After a median of 9.6-11.0 months' remission with osimertinib treatment, tumors will inevitably have progress. (hindawi.com)
  • AT DATA CUTOFF, the median duration of total treatment exposure was 16.2 months in the osimertinib group vs 11.5 months in the standard-TKI group, with 51% and 23% of patients continuing to receive study treatment. (ascopost.com)
  • The median duration of response was two-fold higher for patients treated with osimertinib (17.6 months) compared to standard of care (8.7 months). (ascopost.com)
  • progression
  • At 12 months, 44% of those in the osimertinib arm were progression-free versus 10% in the chemotherapy group. (onclive.com)
  • Osimertinib not only increases progression-free survival but it is well-tolerated, which makes a big difference for our patients. (medicalxpress.com)
  • Patients taking second-line osimertinib had longer progression-free survival and less toxicity than those on chemotherapy. (medicalxpress.com)
  • The progression-free survival benefit for patients with and without brain metastases was almost identical, suggesting that osimertinib is active in the brain as well as in systemic sites. (eurekalert.org)
  • After progression with osimertinib treatment, core needle biopsy was performed and next-generation sequencing was performed. (hindawi.com)
  • Osimertinib significantly improved progression-free survival vs standard EFGR TKI treatment. (ascopost.com)
  • Improvements in PFS with osimertinib were consistent across all pre-specified patient subgroups, with at least a 40% reduction in the risk of progression or death, including in patients with/without central nervous system (CNS) metastases at study entry, Asian/non-Asian patients, patients with/without prior smoking history, and patients with Exon 19 deletion/L858R sensitizing mutations. (astrazeneca-us.com)
  • Osimertinib enables us to respond to this disease progression in a precise and logical way as clearly demonstrated in clinical trials, with potential to make a meaningful difference to the lives of Japanese patients. (astrazeneca.se)
  • 2016
  • First-line treatment with single-agent osimertinib was associated with a 77% response rate in treatment-naïve patients, according to phase I data presented at the 2016 European Lung Cancer Conference (ELCC). (onclive.com)
  • statistically-significant
  • The company reported that osimertinib showed a statistically-significant and clinically-meaningful PFS benefit compared with erlotinib (Tarceva) or gefitinib (Iressa) in treatment-naïve patients. (onclive.com)
  • There was a trend for osimertinib to reduce cough but it was not statistically significant. (medicalxpress.com)
  • There was a trend towards improved emotional and cognitive function with osimertinib but it was not statistically significant. (medicalxpress.com)
  • Overall survival appeared to favour osimertinib with a hazard ratio of 0.63 although this was not statistically significant at the interim overall survival analysis (25% maturity). (eurekalert.org)
  • lung
  • Osimertinib is used to treat a certain type of non-small cell lung cancer. (cigna.com)
  • Osimertinib improves cancer-related symptoms in patients with advanced lung cancer, according to an analysis of patient-reported outcomes from the AURA3 phase III clinical trial presented at the European Lung Cancer Conference (ELCC). (medicalxpress.com)
  • The researchers found that osimertinib significantly reduced many lung cancer symptoms, primarily appetite loss, fatigue, breathlessness and chest pain. (medicalxpress.com)
  • The data presented today shows that second-line osimertinib also significantly improved time to deterioration of important lung cancer symptoms like cough, chest pain and dyspnoea, and improved general health status," continued Peters. (medicalxpress.com)
  • Osimertinib for pretreated EGFR Thr790Met-positive advanced non-small-cell lung cancer (AURA2): a multicentre, open-label, single-arm, phase 2 study. (aacrjournals.org)
  • Giving with osimertinib together with navitoclax may work better in treating EGFR-positive non-small cell lung cancer. (clinicaltrials.gov)
  • Osimertinib or platinum-pemetrexed in EGFR T790M-positive lung cancer. (tagrissohcp.com)
  • Drugs
  • There are 2 first-generation drugs, 1 second-generation drug, and a third-generation drug, osimertinib, which is the newest addition. (onclive.com)