Osimertinib
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Non-small cell lung cancer5 | |||
EGFR exon 19 deletions or exon 21 (L858R) | Monotherapy | Adj. | After complete tumour resection; Stage IB-IIIA |
EGFR exon 19 deletions or exon 21 (L858R) | + pemetrexed and platinum-based chemotherapy | 1L advanced | None |
EGFR mutation | Monotherapy | 1L advanced | None |
EGFR exon 19 deletions or exon 21 (L858R) | Monotherapy | Consol. locally adv. | After platinum-based chemoradiation therapy without disease progression; Unresectable; disease has not progressed during or following platinum-based chemoradiation therapy |
EGFR T790M | Monotherapy | Any line advanced | None |
Full text of section 4.1 (therapeutic indications)
TAGRISSO as monotherapy is indicated for: • the adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations (see section 5.1). • the treatment of adult patients with locally advanced, unresectable NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy. • the first-line treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR mutations. • the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC. TAGRISSO is indicated in combination with: • pemetrexed and platinum-based chemotherapy for the first-line treatment of adult patients with advanced NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.
Label history
31 changes to the Tagrisso label since 2016, 4 of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes