GIOTRIF® (afatinib) is approved in the European Union and other countries for the treatment of patients with metastatic NSCLC whose tumours have epidermal growth factor receptor (EGFR) mutations.
In the U.S., afatinib is approved under the brand name GILOTRIF™. For more information about GILOTRIF™, please visit the US website.
GIOTRIF® is an irreversible ErbB Family Blocker, which blocks EGFR (ErbB1) as well as the other relevant members of the ErbB Family that are known to play a critical role in the growth and spread of the most pervasive cancers and cancers associated with high mortality. The covalent and, therefore, irreversible binding of GIOTRIF® is unlike other compounds which are reversible in that it provides a sustained, selective, and complete ErbB Family Blockade, and therefore may lead to a distinct therapeutic benefit.1,2
In clinical trials, GIOTRIF® 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. shortness of breath, cough and chest pain) and quality of life.3,4 Data from Phase III LUX-Lung 3 trial have shown that patients taking GIOTRIF® as a first-line treatment had a median progression-free survival (PFS) of 11.1 months versus 6.9 months for those treated with pemetrexed/cisplatin. In addition, a subgroup analysis has shown that NSCLC patients with tumours harbouring the two most common EGFR mutations (Del19 or L858R) taking GIOTRIF® had a PFS of 13.6 months versus 6.9 months for those in the comparator arm.3
The most common grade 3 drug-related adverse events observed in the GIOTRIF® treatment arm were diarrhoea (14%), rash (16%), and paronychia (11%). The most common drug-related grade 3 adverse events observed in the chemotherapy arm (pemetrexed/cisplatin) were neutropenia (15%), fatigue (13%), and leucopenia (8%). There was a low discontinuation rate associated with treatment-related adverse events in the trial (8% discontinuation rate for GIOTRIF®; 12% for chemotherapy). 1% of patients in the GIOTRIF® arm discontinued due to drug-related diarrhoea.3