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Tagrisso overall survival

Osimertinib Improves Survival in Advanced Lung Cancer with

  1. The cancer drug osimertinib (Tagrisso) improves survival in people with non-small cell lung cancer with EGFR mutations, updated results from the FLAURA clinical trial show. People treated with osimertinib lived longer than those treated with earlier-generation EGFR-targeted therapies
  2. Results. The median overall survival was 38.6 months (95% confidence interval [CI], 34.5 to 41.8) in the osimertinib group and 31.8 months (95% CI, 26.6 to 36.0) in the comparator group (hazard.
  3. AstraZeneca today announced overall survival (OS) results from the Phase III FLAURA trial of Tagrisso (osimertinib) in the 1st-line treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).. Results showed a statistically significant and clinically meaningful improvement in OS, a key secondary endpoint.
  4. Tagrisso is the only medicine demonstrating statistically-significant overall survival benefit in this setting. Also increased the time patients with central nervous system metastases lived without disease progressio

The median progression-free survival was 18.9 months for TAGRISSO vs 10.2 months for erlotinib or gefitinib.. In the same clinical study, median overall survival was 38.6 months for TAGRISSO vs 31.8 months for erlotinib or gefitinib.. Median is the middle number in a range of numbers.. Progression-free survival (PFS) is the median length of time people are on treatment before their cancer. The median overall survival was 38.6 months for TAGRISSO vs 31.8 months for erlotinib or gefitinib. How the trial worked During the clinical trial, 556 adults with previously untreated stage 4 non-small cell lung cancer with certain abnormal EGFR genes were given treatment with an oral EGFR tyrosine kinase inhibitor (TKI), a type of targeted. DFS results in the overall trial population, Stage IB through IIIA, a key secondary endpoint, demonstrated a reduction in the risk of disease recurrence or death of 79% (based on a HR of 0.21; 95% CI 0.16, 0.28; p<0.0001). At two years, 89% of patients in the trial treated with Tagrisso remained alive and disease free versus 53% on placebo.

Overall survival was the secondary endpoint. Overall, 279 patients received 80 mg of oral Tagrisso once daily and 277 patients were treated with a comparator EGFR-TKI — either 250 mg of Iressa (gefitinib) on daily or 150 mg of Tarceva (erlotinib) once daily From Targeted Oncology. Sequential afatinib (Gilotrif) followed by osimertinib (Tagrisso) has demonstrated a long-term overall survival (OS) of close to 4 years in patients with non-small cell lung cancer (NSCLC) who have EGFR deletion 19 (del19)-positive tumors and acquired T790M mutations, according to interim results released from the real-world GioTag study and published in Future. At the data cutoff date of May 1, 2018, 271 patients (66%) had died, and 140 patients (34%) had discontinued before death. The median overall survival was 26.8 months (95% CI, 24.0-29.1 months); and the 12-month, 24-month, and 36-month survival rates were 80%, 55%, and 37%, respectively Treating physicians and patients continue to participate and remain blinded to treatment. The trial will continue to assess overall survival. Tagrisso Tagrisso (osimertinib) is a third-generation, irreversible EGFR TKI with clinical activity against central nervous system metastases Tagrisso significantly improves overall survival in the Phase III FLAURA trial for 1st-line EGFR-mutated non-small cell lung cancer. AstraZeneca. Posted August 9, 2019

Overall Survival with Osimertinib in Untreated, EGFR

Tagrisso improved overall survival duration compared to Tarceva and Iressa. Median overall survival was 38.6 months compared to 31.8 months with first generation EGFR-TKIs. More than half (54%) of Tagrisso treated patients were alive at three years compared to 44% for Tarceva or Iressa First-line TAGRISSO: The only choice for statistically significant median Overall Survival beyond 3 years 1 OVERALL SURVIVAL IN THE PHASE 3 FLAURA STUDY At 3 years, 54% of TAGRISSO patients and 44% of EGFR-TKI comparator patients were still alive A total of 76 patients progressed, with 47 continuing with osimertinib treatment. These patients exhibited a median second progression-free survival (PFS2) of 12.6 months. Continuation of osimertinib beyond progression was also associated with a longer overall survival (OS) compared with discontinuation (11.2 vs 6.1 months,P= .02)

Tagrisso is the only medicine demonstrating statistically-significant overall survival benefit in this setting. Also increased the time patients with central nervous system metastases lived without disease progression References: 1. TAGRISSO [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2020. 2. Ramalingam SS, Gray JE, Ohe Y, et al. Osimertinib vs comparator EGFR-TKI as first-line treatment for EGFRm advanced NSCLC (FLAURA): final overall survival analysis [oral presentation] Patients treated with TAGRISSO had a median Overall Survival beyond 3 years 1 HR=0.80 (95% CI: 0.64, 1.00); N=556 Crossover to TAGRISSO was allowed for patients receiving erlotinib/gefitinib at confirmed progression if positive for the EGFR T790M resistance mutation

Overall survival (OS) data were not presented due to not reaching maturity. Adverse events (AEs) leading to treatment discontinuation were similar between arms, at 3.7% for aumolertinib and 5.1% for Iressa, as were the grade ≥ 3 AEs, at 36.4% and 35.8% respectively TAGRISSO is the only medicine demonstrating statistically-significant overall survival benefit in this setting. Also increased the time patients with central nervous system metastases lived.

Efficacy of TAGRISSO® (osimertinib)

Tagrisso is the only 1st-line treatment for EGFR-mutated

Overall survival (OS) is the length of time people are on treatment and still living. Important Safety Information. TAGRISSO may cause serious side effects, including: lung problems. TAGRISSO may cause lung problems that may lead to death. Symptoms may be similar to symptoms from lung cancer. Tell your healthcare provider right away if you have. After a median follow-up for this study was 32.5 months (IQR, 13.35-42.06), there was a median overall survival (OS) of 29.9 months (95% CI, 18.2-not reached [NR]) for the whole group. Overall, the median progression-free survival (PFS) was 17.5 months for all patients (95% CI, 15.7-33.3) TAGRISSO® (OSIMERTINIB) Significantly Improves Overall Survival in the Phase III FLAURA Trial for 1st-line EGFR-mutated Non-small Cell Lung Cancer TAGRISSO is the only medicine demonstrating. Find Assistance and Payment Information For Eligible Patients. Learn How CYRAMZA® Works And How It May Help Eligible Patients

Median overall survival (OS) was improved by 6.8 months with osimertinib (Tagrisso) as a first-line treatment for patients with metastatic,EGFR-mutant non small cell lung cancer (NSCLC) compared with erlotinib (Tarceva) or gefitinib (Iressa), despite crossover between arms, according to updated data from the phase III FLAURA study presented at. Sequential afatinib (Gilotrif) followed by osimertinib (Tagrisso) has demonstrated a long-term overall survival (OS) of close to 4 years in patients with non small cell lung cancer (NSCLC) who have EGFR deletion 19 (del19) positive tumors and acquired T790M mutations, according to interim results released from the real-world GioTag study and.

AZ' Tagrisso improves overall survival in lung cancer. AstraZeneca has announced positive overall survival (OS) results from the Phase III FLAURA trial, evaluating Tagrisso (osimertinib) in previously-untreated patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC). The trial tested the drug in patients whose tumours. The trial will continue to assess overall survival. About TAGRISSO. TAGRISSO ® (osimertinib) is a third-generation, irreversible EGFR-TKI with clinical activity against central nervous system. Overall treatment with Tagrisso improved progression-free survival by 54%. The overall response to treatment was 80% with Tagrisso compared to 75% with standard of care treatment. The average duration of response was two-fold higher for patients treated with Tagrisso (17.6 months) compared to standard of care (8.7 months) Tagrisso (osimertinib) is an The primary end point was disease-free survival (DFS) among patients with stage 2 to stage 3a disease. Secondary end points were DFS in the overall population of patients with stage 2b to stage 3a disease, overall survival (OS), health-related quality of life and safety. 9,10

Tagrisso significantly improves overall survival in the

  1. AstraZeneca has the improvement in overall survival (OS) it needed for lung cancer therapy Tagrisso (osimertinib), as it tries to double down on its use in the first-line setting. Updated results from the FLAURA trial show that Tagrisso extends survival in previously-untreated patients with EGFR-positive non-small cell lung cancer (NSCLC.
  2. Treatment with Tagrisso (osimertinib) following surgery is the first targeted agent in a global randomized trial to demonstrate statistically significant improvement of disease-free survival (DFS) in patients with stage 2-3A EGFR mutation-positive non-small cell lung cancer (NSCLC), according to results from the ADAURA trial presented at the 2020 American Society of Clinical Oncology (ASCO.
  3. Data on overall survival were immature at the interim analysis (25% maturity). The survival rate at 18 months was 83% (95% CI, 78 to 87) with osimertinib and 71% (95% CI, 65 to 76) with standard.

A relative survival rate compares people with the same type and stage of cancer to people in the overall population. For example, if the 5-year relative survival rate for a specific stage of lung cancer is 60%, it means that people who have that cancer are, on average, about 60% as likely as people who don't have that cancer to live for at. Final results show overall survival is prolonged with osimertinib compared to either gefitinib or erlotinib Suresh S. Ramalingam, Haematology and Medical Oncology, Emory University, Winship Cancer Institute in Atlanta, United States of America, reported the final OS results from an analysis done at 58% maturity of OS data from the phase III.

In the Stage II and IIIA group, Tagrisso decreased the risk of disease recurrence or death by 83%. In the overall trial population, Stage IB through IIIA, which was a key secondary endpoint, the drug showed a decrease in DFS of 79%. The EGFR mutation has been identified in about 25% of lung cancer cases worldwide, but in Asia can exceed 40% Tagrisso significantly improves overall survival in the Phase III FLAURA trial for 1st-line EGFR-mutated non-small cell lung cancer Tagrisso is the only medicine demonstrating statistically-significant overall survival benefit in this setting. Also increased the time patients with central nervous system metastases lived without disease progressio Investigators and patients continue to participate and remain blinded to treatment. The trial will continue to assess overall survival. Tagrisso. Tagrisso (osimertinib) is a third-generation, irreversible EGFR-TKI with clinical activity against CNS metastases

Treatment for Stage 4 EGFR+ NSCLC - TAGRISSO® (osimertinib

  1. Tagrisso has been shown to give people more time in which the cancer did not get worse. The median progression-free survival was 18.9 months for Tagrisso vs 10.2 for standard chemotherapy. People treated with Tagrisso also lived longer: the median overall survival was 38.6 months for Tagrisso vs 31.8 months for standard chemotherapy.
  2. WILMINGTON, Del.-(BUSINESS WIRE)-AstraZeneca today presented detailed overall survival (OS) results from the Phase III FLAURA trial of TAGRISSO® (osimertinib) in the 1st-line treatment of adult patients with locally-advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).Results showed a statistically significant and clinically meaningful.
  3. Background: In AURA3 (NCT02151981), osimertinib, a third-generation epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI), significantly prolonged progression-free survival and improved response in patients with EGFR T790M advanced non-small-cell lung cancer (NSCLC) and progression on prior EGFR-TKI treatment.We report the final AURA3 overall survival (OS) analysis
  4. TAGRISSO is the only medicine demonstrating statistically-significant overall survival benefit in this setting. Also increased the time patients with central nervous system metastases lived without disease progression (WILMINGTON, Del., August 9, 2019) AstraZeneca today announced positive overall survival (OS) results from the Phase III FLAURA trial, a randomized, double-blinded, multicenter.

Clinical Trial Results - TAGRISSO® (osimertinib

NEW YORK - Results from the Phase III randomized ADAURA trial demonstrated a compelling disease-free survival benefit from the adjuvant use of osimertinib (AstraZeneca's Tagrisso) in patients with stage IB-IIIA non-small cell lung cancer after complete tumor resection, according to data announced as part of the American Society of Clinical Oncology's virtual annual meeting Tagrisso is the only 1st-line treatment for EGFR-mutated non-small cell lung cancer to deliver a median overall survival of more than three years. PUBLISHED 1 October 2019. 28% of patients in the global FLAURA trial were still receiving Tagrisso at three years vs. 9% on either gefitinib or erlotinib

Tagrisso demonstrated unprecedented disease-free survival

Tagrisso significantly improves overall survival in the Phase III FLAURA trial for 1st-line EGFR-mutated non-small cell lung cancer Posted August 9th, 2019 for AstraZeneca Tagrisso is the only medicine demonstrating statistically-significant overall survival benefit in this setting Several published cases reported 3-year survival for metastatic lung cancer patients. All were treated with at least one EGFR TKI line . Oncogenic addiction of EGFR-mutated NSCLC lung cancer is well-known: the timing of the first TKI administration does not impact the response rate, nor patients' overall survival ASCO: Pfizer's dacomitinib bests Iressa in NSCLC overall survival showdown. Tagrisso may have an edge over dacomitinib in terms of safety and its ability to treat patients with CNS metastases. AstraZeneca announced positive overall survival results from the phase 3 FLAURA trial on Friday - a randomised, double-blinded, multi-centre trial of 'Tagrisso' (osimertinib) in previously.

Frontline Tagrisso Improves Survival Among Specific

In this exploratory analysis of the overall trial population, adjuvant Tagrisso reduced the risk of disease recurrence or death by 84% in patients who had been treated with prior adjuvant chemotherapy (based on a hazard ratio [HR] of 0.16, 95% confidence interval [CI] 0.10-0.26) and by 77% in patients who had not (HR 0.23; 95% CI 0.13-0.40. WILMINGTON, Del.--(BUSINESS WIRE)-- AstraZeneca today announced positive overall survival (OS) results from the Phase III FLAURA trial, a randomized, double-blinded, multicenter trial of TAGRISSO in previously-untreated patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) mutations DFS results in the overall trial population, Stage IB through IIIA, a key secondary endpoint, demonstrated a reduction in the risk of disease recurrence or death of 79% (based on a HR of 0.21; 95%. The ASCO presentation provided data on Tagrisso's effect in improving disease-free survival (DFS)—the primary endpoint—compared to placebo when used as adjuvant therapy. While the DFS hazard ratio of 0.21 (p<0.0001) in the overall study population w striking, the data was still inadequate to change treatment practice without mature. Phase III ADAURA trial showed AstraZeneca's Tagrisso demonstrated significant and clinically meaningful improvement in disease-free survival

Long-Term Survival for EGFR+ Lung Cancer Foundation of

  1. The trial also showed a statistically significant and clinically meaningful improvement in DFS for Tagrisso in the overall trial population, a key secondary endpoint. While up to 30% of all patients with NSCLC may be diagnosed early enough to have surgery with curative intent, recurrence is still common in early-stage disease
  2. Adjuvant TAGRISSO® in Resected EGFR-Mutated Non-Small Cell Lung Cancer. SUMMARY: Lung cancer is the second most common cancer in both men and women and accounts for about 14% of all new cancers and 27% of all cancer deaths. The American Cancer Society estimates that for 2020, about 228, 820 new cases of lung cancer will be diagnosed and.
  3. Tagrisso Shows Superiority vs. Chemo in EGFR T790M Mutation-Positive Disease. Data from phase III trial showed that Tagrisso (osimertinib) second-line therapy improved progression-free survival by 5.7 months, compared with standard platinum-based doublet chemotherapy (Hazard Ratio [HR]=0.3). Tagrisso is sponsored by AstraZeneca
  4. TAGRISSO Is the Only 1st-line Treatment for EGFR-Mutated Non-Small Cell Lung Cancer to Deliver a Median Overall Survival of More Than Three Years 28% of patients in the global FLAURA trial were.
  5. TAGRISSO reduced risk of disease progression by 70% and improved progression-free survival (PFS) by almost six months. Patients with central nervous system (CNS) metastases achieved consistent results with the overall patient population in pre-specified exploratory subgroup analysi

The trial will continue to assess overall survival. Tagrisso Tagrisso (osimertinib) is a third-generation, irreversible EGFR TKI with clinical activity against central nervous system metastases. Tagrisso (40mg and 80mg once-daily oral tablets) has been used to treat more than 250,000 patients across indications worldwide and AstraZeneca. In April an Independent Data Monitoring Committee recommended for the Phase III ADAURA trial to be unblinded two years early based on its determination of 'overwhelming efficacy'. At the time of data cut-off, overall survival (OS) data favoured Tagrisso, but were not mature. The trial will continue to assess OS as a secondary endpoint, AZ said Overall, Tagrisso reduced the risk of lung cancer relapse by 83% compared to placebo, the strongest result ever reported for a clinical trial of this type.. Market Summary > AstraZeneca plc NYSE: AZN . After hours $56.77 +3.27 (+6.11%) $53.50 USD +1.03 (+1.96%) Closed: May 28, 202 Patients with Del19 mutation-positive NSCLC seemed to benefit particularly well, experiencing a median overall survival of 45.7 months, with 82 percent alive at two years. Median time to treatment failure (TTF), the primary study outcome, for sequential afatinib and osimertinib was 28.1 months in the overall cohort and 30.6 months in those with. The 2-year DFS rate in this patient group with TAGRISSO® was 90% versus 44% with placebo. In the overall population, the DFS was still not reached with TAGRISSO® versus 28.1 months with placebo (HR=0.21; P<0.0001). The 2-year DFS rate in the overall population was 89% with TAGRISSO® versus 53% with placebo

Osimertinib in patients with T790M mutation-positive

AstraZeneca's Tagrisso is already rolling in EGFR-mutated lung cancer, but new survival data could help spur additional reimbursement. Saturday at the European Society for Medical Oncology. Secondary endpoints: DFS in overall population, DFS at 2, 3, and 5 years, overall survival, safety, health-related quality of life 1,3 The ADAURA study was powered to show a hazard ratio (HR) of 0.7 in favour of the TAGRISSO arm In the Stage II and IIIA group, Tagrisso decreased the risk of disease recurrence or death by 83%. In the overall trial population, Stage IB through IIIA, which was a key secondary endpoint, the drug showed a decrease in DFS of 79%. The EGFR mutation has been identified in about 25% of lung cancer cases worldwide, but in Asia can exceed 40% People with early-stage lung cancer who have certain mutations in the EGFR gene are significantly more likely to be cancer-free two years later if they receive the targeted therapy Tagrisso (osimertinib) after surgery than if they receive a placebo, according to data from an ongoing clinical trial presented May 31, 2020, at the annual meeting of the American Society of Clinical Oncology (ASCO) The new indication for osimertinib (Tagrisso) marks the first FDA approval of an adjuvant treatment for non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R mutations

Tagrisso approved in the EU for the adjuvant treatment of

The data readout was originally anticipated in 2022. The trial will continue to assess overall survival. Tagrisso. Tagrisso (osimertinib) is a third-generation, irreversible EGFR-TKI with clinical activity against central nervous system metastases Overall response rate was 80%, median progression-free survival 12.1 months (95% CI 8.3-18.3), median overall survival 28 months (95% CI 20.2-not reached [NR]) and median treatment duration 18.8 months (95%CI 16-8-NR). PD occurred in 36 patients (72%). 73% had oligo-PD. Median osimertinib treatment duration in patients with oligo-PD was 19.6 vs. Disease-free survival is not the same as overall survival, which is typically considered the most definitive measure of how beneficial a drug is. Since the trial was stopped early, there's not yet enough information to compare Tagrisso's effect on overall survival to placebo

Osimertinib Improves Survival in Frontline EGFR+ NSCL

The major efficacy outcome measure was progression-free survival (PFS), as assessed by investigator. Additional efficacy outcome measures included overall survival (OS) and overall response rate (ORR). A total of 556 patients were randomized to Tagrisso (n=279) or to control (gefitinib n=183; erlotinib n=94) The data readout was originally anticipated in 2022. The trial will continue to assess overall survival. About TAGRISSO TAGRISSO ® (osimertinib) is a third-generation, irreversible EGFR-TKI with. AstraZeneca's EGFR-inhibitor has now demonstrated an 'overwhelming' disease-free survival and CNS recurrence benefit, but overall survival benefit remains unknown. ADAURA Analysis Shows Adjuvant Tagrisso Curbs Brain Metastases in EGFR-Mutated NSCLC | Precision Oncology New The British drugmaker announced overall positive survival results from the study of the treatment in patients with epidermal growth factor receptor-mutated metastatic non-small cell lung cancer

Asco 2020 – Tagrisso shows what early targeting can do

TAGRISSO Extended Disease-Free Survival Regardless of

A statistically significant benefit was not observed in terms of overall survival (OS) with the EGFR tyrosine kinase inhibitor (TKI) osimertinib (Tagrisso) compared with platinum-pemetrexed therapy as treatment of patients with EGFR T790M-mutated advanced non-small cell lung cancer (NSCLC), according to the final OS data from the AURA3. The data readout was originally anticipated in 2022. The trial will continue to assess overall survival. About TAGRISSO. TAGRISSO® (osimertinib) is a third-generation, irreversible EGFR-TKI with. Briefly, oral osimertinib (80 mg, once daily) was compared with placebo for a treatment duration of up to 3 years or until disease recurrence; median duration of exposure was 22.3 months (range 0-43). The primary endpoint was disease-free survival (DFS), and the key secondary endpoint was overall survival (OS) Further analyses of the study are ongoing, specifically for overall survival, according to AstraZeneca. The company plans to present results from the AURA3 trial at an upcoming medical meeting. Findings from the phase 3 trial will serve as confirmatory findings for an accelerated FDA approval received by Tagrisso in November 2015 Then, last summer, AZ presented new data showing Tagrisso extended the lives of lung cancer patients by a median of 38.6 months, while older EGFR inhibitors posted survival gains of 31.8 months

TAGRISSO® (osimertinib) | Official Global Site

AURA3 Clinical Study Data - TAGRISSO® (osimertinib

Tagrisso Could Be Used Before Surgery in the Future. progression-free survival and overall survival is short because resistance to platinum-based chemotherapy occurs, Dr. Powles said. The. Tagrisso. August 15, 2020 FDA OKs Liquid Biopsy to Identify EGFR-Positive Lung CancerBookmark George Lundberg, MD. Article from MedPage Today curated by Editor in Chief George Lundberg, MD, who notes: . The U.S. Food and Drug Administration (FDA) has approved a liquid biopsy test (a type of biopsy that uses a blood draw instead of surgery) for detecting whether patients have EGFR mutations in. Overall, the analysis suggested that fewer patients treated with Tagrisso in the adjuvant setting had recurrence events or deaths, compared to the placebo. Among the subjects whose cancer returned, 38% of those who received Tagrisso had a metastatic recurrence, compared to 61% of patients who received a placebo TAGRISSO is a type of drug that targets EGFR sensitising mutations and T790M mutations. TAGRISSO may help prevent your lung cancer from coming back after removal of the tumour by surgery. It may also help to slow or stop your lung cancer from growing or help to shrink the tumour. TAGRISSO has been shown to produce effects on the tumour within 6 t Latest Overall Survival Finding Keeps Tagrisso As Top Treatment Option. The phase 3 study in question is known as FLAURA. This study recruited a total of 556 patients who were randomized into two.

ASCO 2020: Results From the Phase 3 ADAURA Tria

(Corrects Aug. 9 story to show study points to overall survival and not progression free survival in first paragraph) AstraZeneca's Tagrisso helps lung cancer patients live longer: study | R. Pharmacology refers to the chemical makeup and behavior of TAGRISSO (osimertinib tablet, film coated) The trial will continue to assess overall survival. Tagrisso. Tagrisso (osimertinib) is a third-generation, irreversible EGFR TKI with clinical activity against central nervous system metastases

TAGRISSO® (osimertinib) | EfficacyAURA3 Clinical Study Data | TAGRISSO® (osimertinib)TAGRISSO 80 mg film-coated tablets - Summary of Product

Roche's IMpower010 trial results warrant evidence on survival impact for Tecentriq adoption in non-small cell lung cancer. By Manasi Vaidya 02 Jun 2021. The adoption of Roche's Tecentriq (atezolizumab) as an adjuvant treatment in non-small cell lung cancer (NSCLC) is unlikely without a survival improvement, most experts said, despite the. TAGRISSO is the only medicine demonstrating statistically-significant overall survival benefit in this setting. Also increased the time patients with central nervous system metastases lived without disease progressio The FDA has approved Tagrisso® (osimertinib) as adjuvant therapy after tumor resection in patients with NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by.