TAGRISSO (osimertinib)

• Key points

Favourable opinion for reimbursement as monotherapy in the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations.

• What therapeutic improvement?

TAGRISSO provides a therapeutic improvement compared to other anti-EGFR TKIs in the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with mutations (EGFR).

• Role in the care pathway?

In the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations, when the use of an anti-EGFR TKI isconsidered, osimertinib is the first-line treatment of choice due to demonstration of an improvement in overall survival compared to erlotinib and gefitinib with a safety profile judged to be acceptable.

The Committee reiterates that patients with EGFR mutations other than exon 19 deletion or exon 21 (L858R) activating mutations (in particular the T790M mutation for which osimertinib has an MA and a specific Committee opinion) were not assessed in the FLAURA study. Exons 19 or 21 mutations represent the majority of all EGFR mutations (85%)^{[1] [2]}