EMA Recommends Extending Indications for Afatinib

New indication concerns the treatment of locally advanced or metastatic NSCLC of squamous histology progressing on or after platinum-based chemotherapy

On 25 February 2016, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product afatinib (Giotrif).

The marketing authorisation holder for this medicinal product is Boehringer Ingelheim International GmbH.

The CHMP adopted a new indication as follows:

“Giotrif as monotherapy is indicated for the treatment of locally advanced or metastatic NSCLC of squamous histology progressing on or after platinum-based chemotherapy.”

For information, the full indications for Giotrif will be as follows:

“Giotrif as monotherapy is indicated for the treatment of

  • Epidermal Growth Factor Receptor (EGFR) TKI-naive 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.”

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics, which will be published in the revised European public assessment report, and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.