ADAURA

TAGRISSO Extended Disease-Free Survival Regardless of Prior Adjuvant Chemotherapy in Early-Stage EGFR-Mutated Lung Cancer

Retrieved on: 
Friday, January 29, 2021

In the ADAURA Phase III trial, chemotherapy use was balanced across the two treatment arms, with 60% of patients receiving prior adjuvant chemotherapy.

Key Points: 
  • In the ADAURA Phase III trial, chemotherapy use was balanced across the two treatment arms, with 60% of patients receiving prior adjuvant chemotherapy.
  • If no other etiology can be identified, consider permanent discontinuation of TAGRISSO based on severity
    Verify pregnancy status of females of reproductive potential prior to initiating TAGRISSO.
  • Adjuvant Chemotherapy for Resectable Non-Small-Cell Lung Cancer: Where is it Going?
  • EGFR Mutation Testing in Lung Cancer: a Review of Available Methods and Their Use for Analysis of Tumour Tissue and Cytology Samples.

TAGRISSO Approved in the US for the Adjuvant Treatment of Patients With Early-Stage EGFR-mutated Lung Cancer

Retrieved on: 
Monday, December 21, 2020

TAGRISSO is indicated for EGFRm patients whose tumors have exon 19 deletions or exon 21 L858R mutations as detected by an approved test.

Key Points: 
  • TAGRISSO is indicated for EGFRm patients whose tumors have exon 19 deletions or exon 21 L858R mutations as detected by an approved test.
  • We remain committed to treating cancer patients earlier, when they may still have a chance of being cured.
  • TAGRISSO was recently granted Breakthrough Therapy Designation for patients in the early-stage disease setting by the US FDA.
  • In China, TAGRISSO is under priority review for the adjuvant treatment of patients with early-stage EGFRm NSCLC based on the ADAURA Phase III trial.

TAGRISSO Reduced the Risk of Disease Recurrence in the Brain by 82% in the Adjuvant Treatment of Early-Stage EGFR-Mutated Lung Cancer

Retrieved on: 
Saturday, September 19, 2020

Conduct cardiac monitoring, including assessment of LVEF at baseline and during treatment, in patients with cardiac risk factors.

Key Points: 
  • Conduct cardiac monitoring, including assessment of LVEF at baseline and during treatment, in patients with cardiac risk factors.
  • For symptomatic congestive heart failure, permanently discontinue TAGRISSO
    Keratitis was reported in 0.7% of 1142 patients treated with TAGRISSO in clinical trials.
  • Withhold TAGRISSO if SJS or EMM is suspected and permanently discontinue if confirmed
    Verify pregnancy status of females of reproductive potential prior to initiating TAGRISSO.
  • Patients were treated with TAGRISSO 80 mg once-daily oral tablets or placebo for three years or until disease recurrence.

TAGRISSO Granted Breakthrough Therapy Designation in the US for the Adjuvant Treatment of Patients With Stage IB-IIIA EGFR-mutated Lung Cancer

Retrieved on: 
Thursday, July 30, 2020

Conduct cardiac monitoring, including assessment of LVEF at baseline and during treatment, in patients with cardiac risk factors.

Key Points: 
  • Conduct cardiac monitoring, including assessment of LVEF at baseline and during treatment, in patients with cardiac risk factors.
  • For symptomatic congestive heart failure, permanently discontinue TAGRISSO
    Keratitis was reported in 0.7% of 1142 patients treated with TAGRISSO in clinical trials.
  • Advise females of reproductive potential to use effective contraception during treatment with TAGRISSO and for 6 weeks after the final dose.
  • The primary endpoint is DFS in Stage II and IIIA patients and a key secondary endpoint is DFS in Stage IB, II and IIIA patients.

TAGRISSO Demonstrated Unprecedented Patient Benefit in the Adjuvant Treatment of EGFR-Mutated Lung Cancer

Retrieved on: 
Thursday, May 28, 2020

For symptomatic congestive heart failure, permanently discontinue TAGRISSO

Key Points: 
  • For symptomatic congestive heart failure, permanently discontinue TAGRISSO
    Keratitis was reported in 0.7% of 1142 patients treated with TAGRISSO in clinical trials.
  • Withhold TAGRISSO if SJS or EMM is suspected and permanently discontinue if confirmed
    Verify pregnancy status of females of reproductive potential prior to initiating TAGRISSO.
  • Advise females of reproductive potential to use effective contraception during treatment with TAGRISSO and for 6 weeks after the final dose.
  • Le Chevalier T. Adjuvant chemotherapy for resectable non-small-cell lung cancer: where is it going?