Afatinib
Afatinib (Giotrif, Boehringer Ingelheim International GmbH) has 2 EU-approved indications in 1 tumour type. 1 needs a biomarker result: EGFR (1).
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Non-small cell lung cancer2 | |||
None | Monotherapy | 2L advanced | Squamous only; Progressed on or after platinum-based chemotherapy |
Activating EGFR mutation(s) | Monotherapy | Any line advanced | EGFR TKI-naïve |
Full text of section 4.1 (therapeutic indications)
GIOTRIF as monotherapy is indicated for the treatment of • Epidermal Growth Factor Receptor (EGFR) TKI-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s); • Adult patients with locally advanced or metastatic NSCLC of squamous histology progressing on or after platinum-based chemotherapy (see section 5.1).
Label history
20 changes to the Giotrif label since 2016, 1 of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes