Giotrif (afatinib)
- Region
- 🇪🇺 EU
- Active substance
- afatinib
- Company
- Boehringer Ingelheim International GmbH
- Status
- Authorised
- Therapeutic area
- Carcinoma, Non-Small-Cell Lung
- CHMP opinion
- Thu 25 Jul 2013
- EU approval
- Wed 25 Sep 2013
- Application
- EMEA/H/C/002280
- ATC
- L01XE13
- Official record
- www.ema.europa.eu
Indication
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); locally advanced or metastatic NSCLC of squamous histology progressing on or after platinum-based chemotherapy.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.