Giotrif (afanitib) tablets

Afatinib* as monotherapy is authorised for the treatment of tyrosine kinase inhibitor-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s). It is also registered for the treatment of patients with locally advanced or metastatic NSCLC of squamous histology progressing on or after platinum-based chemotherapy.1 In the European Union (EU) and other countries, afatinib is approved under the brand name GIOTRIF®, and in the United States (US) it is approved under the brand name GILOTRIF®.

About afatinib

Afatinib is a potent and selective, irreversible ErbB Family Blocker. Afatinib covalently binds to and irreversibly blocks signalling from all homodimers and heterodimers formed by the ErbB Family members EGFR (ErbB1), HER2 (ErbB2), ErbB3 and ErbB4. The irreversible binding of afatinib is unlike the reversible binding of other compounds, it provides a sustained, selective, and complete blockade of ErbB Family members, and therefore may lead to a distinct therapeutic benefit.1–3

In clinical trials, afatinib has been shown to offer patients with NSCLC a significant delay in tumour progression, coupled with improvements in their lung cancer-related symptoms (e.g. dyspnoea, cough and chest pain) and quality of life.4,5 Afatinib approval, both in the US and the EU, was primarily based on data from the Phase III LUX-Lung 3 trial, in which patients with advanced (IIIb/IV) NSCLC with adenocarcinoma histology received afatinib as first-line treatment. A median progression-free survival (PFS) of 11.1 months vs 6.9 months for those treated with pemetrexed/cisplatin. In addition, a subgroup analysis has shown that patients with NSCLC with tumours harbouring the two most common EGFR mutations (Del19 or L858R) taking afatinib had a PFS of 13.6 months vs 6.9 months (p<0.0001) for those in the comparator arm. Furthermore, those with del19 mutation demonstrated ≥1 year overall survival (OS) benefit (median 33.3 vs 21.1 months, p=0.0015) with afatinib compared with the comparator.4

The European Committee for Medicinal Products for Human Use and the FDA have recommended approval of afatinib in patients with advanced squamous cell cancer of the lung, based on results from the LUX-Lung 8 trial.

For further information on afatinib please see:
  1. GIOTRIF Summary of product characteristics. Available at: (Accessed: May 2016).
  2. Solca F, Dahl G, Zoephel A, et al. Target binding properties and cellular activity of afatinib, an irreversible ErbB family blocker. J Pharmacol Exp Ther 2012;343:342-350.
  3. Reid A, Vidal L, Shaw H, de Bono J. Dual inhibition of ErbB1 (EGFR/HER1) and ErbB2 (HER2/neu). Eur J Cancer 2007;43:481-489.
  4. Sequist LV, Yang JC, Yamamoto N et al. Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with epidermal growth factor receptor mutations. J Clin Oncol 2013;31:3327-3334.
  5. Yang JC, Hirsh V, Schuler M, et al. Symptom control and quality of life in LUX-Lung 3: a phase iii study of afatinib or cisplatin/pemetrexed in patients with advanced lung adenocarcinoma with epidermal growth factor receptor mutations. J Clin Oncol 2013;31:3342-3350.