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Company: AstraZeneca
Approval Status: FDA Approved November 2015
Specific Treatments: EGFR T790M mutation positive non-small cell lung cancer
Drug: Osimertinib



Tagrisso (osimertinib) is an EGFR-TKI, a targeted cancer therapy, designed to inhibit both the activating, sensitizing mutations (EGFRm), and T790M, a genetic mutation responsible to EGFR-TKI treatment resistance.

Tagrisso is specifically indicated for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer, as detected by an FDA-approved test, who have progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy. 

Tagrisso is supplied as a tablet for oral administration. The recommended dose is 80 mg tablet once a day until disease progression or unacceptable toxicity. Tagrisso can be taken with or without food. If a dose is missed, do not make up the missed dose and take the next dose as scheduled. 



FDA Approval

This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Tagrisso is being studied in the confirmatory trial, AURA3, an open label, randomized Phase III study designed to assess the efficacy and safety versus platinum-based doublet chemotherapy in patients with EGFR T790M positive, locally advanced, or metastatic NSCLC who have progressed following prior therapy with an EGFR-TKI. 

The FDA approval of Tagrisso was based on data from two phase II studies (AURA extension and AURA2) which demonstrated efficacy in 411 EGFRm T790M NSCLC patients that had progressed on or after an EGFR TKI. In those trials, overall objective response rate (ORR) was 59%. In a separate part of the AURA Study in 63 patients, ORR was 51% and median duration of response was 12.4 months.



Adverse effects associated with the use of Tagrisso may include, but are not limited to, the following:

  • diarrhea
  • rash
  • dry skin
  • nail toxicity



Tagrisso (osimertinib) is kinase inhibitor of the epidermal growth factor receptor (EGFR), which binds irreversibly to certain mutant forms of EGFR (T790M, L858R, and exon 19 deletion) at approximately 9-fold lower concentrations than wild-type.

Source: centerwatch