TAGRISSO (osimertinib)

TAGRISSO (osimertinib) is an EGFR TKI indicated for adult patients with locally advanced or metastatic EGFR T790M mutation-positive non-small cell lung cancer (NSCLC).1

Prescribing information

Dosing

TAGRISSO offers convenient, once-daily dosing1

Image showing TAGRISSO tablet dose
Image showing TAGRISSO tablet dose
 

Administration options:1

TAGRISSO is a once daily, 80 mg tablet
TAGRISSO is a once daily, 80 mg tablet

TAGRISSO is a once daily, 80 mg tablet1

TAGRISSO may be taken with or without food
TAGRISSO may be taken with or without food

TAGRISSO may be taken with or without food1

TAGRISSO can be dissolved in water and swallowed or taken through an NG tube
TAGRISSO can be dissolved in water and swallowed or taken through an NG tube

TAGRISSO can be dissolved in water and swallowed or taken through an NG tube1*

In patients treated with TAGRISSO 80 mg once daily, 2.3% had a dose reduction and 6.5% discontinued treatment due to adverse reactions or abnormal laboratory parameters.1

* TAGRISSO should not be crushed, split or chewed.1
TAGRISSO is not recommended in patients with severe hepatic impairment due to lack of current data.1

Some situations may require dose interruption or discontinuation:1

Image showing TAGRISSO tablet dose
Image showing TAGRISSO tablet dose

Tolerability

Most adverse events with TAGRISSO in the AURA3 clinical trial were mild to moderate (see study details below).2

AEs at a maximum grade of 1 were reported in 33% of the TAGRISSO group and in 11% of the platinum–pemetrexed group. AEs seen with platinum-pemetrexed tended to be more severe, despite the longer treatment duration with TAGRISSO.2
Any grade
Any grade
Grade 3
Grade 3

Testing for the T790M mutation

Test for EGFR T790M at the first sign of progression.

Incorporating both plasma-based and tissue-based tests into your practice may identify more patients with the EGFR T790M mutation.3
Example testing sequence: begin with a blood (plasma) ctDNA test: if negative, follow-up with a tissue test
Example testing sequence: begin with a blood (plasma) ctDNA test: if negative, follow-up with a tissue test

In the instance of a negative outcome, a follow-up biopsy is recommended due to the possibility of false negatives in plasma-based testing1,4

Plasma and tissue tests are complementary approaches when testing for the T790M mutation

Plasma-based (ctDNA) testing:

  • More rapid turnaround time3,5
  • Less invasive collection procedure3,5
  • May better reflect disease status (primary and metastatic sites)3,5
  • Due to differences in tumour biology, a negative plasma-based test may not provide conclusive results3
  • Plasma assays can vary in sensitivity,6 may yield false negative results;3 negative plasma tests should undergo a follow-up tissue biopsy1

Tissue-based testing:

  • Commonly performed and standardized testing method3
  • High sensitivity of the clinical test helps to identify patients with the mutations and may allow for identification of other resistance mechanisms7
  • Not all patients can receive a biopsy due to:3,5
  •                      o Performance status
                         o Tumour location
                         o The ability to obtain sufficient tumour material

  • There may be potential complications involved with the collection process3
  • Heterogeneity of the sample may cause identification issues3

ctDNA testing offers a specific and sensitive method to assess EGFR mutation status3,6

In the instance tumour tissue is not available, ctDNA testing offers an accurate method to assess mutation status.6

Percent agreement* of the cobas® plasma test with the cobas® tissue test,** % (95% CI)

Detection rate
Detection rate

Adapted from Wu YL et al. 2017.

* Positive and negative percent agreements used here as measures of test sensitivity and specificity, respectively, and calculated with invalid results excluded.6
** The cobas® test is a real-time PCR test for qualitative mutation detection with the EGFR gene.6
Patient numbers are those patients with tissue mutation-positive status excluding patients from China due to plasma sample export limitations.6