Drugs Xagena
The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Giotrif 20 mg, 30 mg, 40 mg and 50 mg film-coated tablets intended for the treatment of EGFR TKI-naïve adult patients with locally advanced or metastatic non-small cell lung cancer ( NSCLC ) with activating EGFR mutation(s).
The active substance of Giotrif is Afatinib, an antineoplastic agent, protein kinase inhibitor, that covalently binds to and irreversibly blocks signalling from all homo- and heterodimers formed by the ErbB family members EGFR ( ErbB1 ), HER2 ( ErbB2 ), ErbB3 and ErbB4.
The benefits with Giotrif have been shown in a phase III, randomised, open-label study of Afatinib versus chemotherapy in patients with locally advanced or metastatic non-small cell lung cancer with activating EGFR mutation(s). In this study efficacy has been shown in terms of an increased progression free survival in patients receiving Afatinib compared to chemotherapy.
The most common side effects are diarrhea, stomatitis, rash, dermatitis acneiform, pruritus, dry skin, paronychia, decreased apetite and epistaxis.
The approved indication is: 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 with activating EGFR mutation(s). ( Xagena )
Source: European Medicines Agency ( EMA ), 2013
XagenaMedicine_2013
