On August 19, 2015 Boehringer Ingelheim reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for an update to the European label for Giotrif (afatinib*), strengthening and broadening the efficacy profile based on additional Phase III data (Press release, Boehringer Ingelheim, AUG 18, 2015, View Source [SID:1234507295]).

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The CHMP recommendation includes data from the LUX-Lung 3 and 6 trials which showed patients whose tumours have the most common EGFR mutation (deletion in exon 19; del19) lived more than one year longer when treated with first-line Giotrif compared to standard chemotherapy (overall survival; OS = secondary endpoint, progression-free survival; PFS = primary endpoint).1

Dr. Mehdi Shahidi, Medical Head, Solid Tumour Oncology, Boehringer Ingelheim commented, "This update to the European label reinforces the importance of Giotrif as a targeted treatment for patients with EGFR mutation-positive NSCLC, especially for those whose tumours harbor the most common mutation, del19. Giotrif is the first and only targeted agent to date to have shown an overall survival benefit for these patients in the first-line setting."

Following CHMP positive opinion, the European prescribing information will now be updated to include additional data from LUX-Lung 3 and LUX-Lung 6. Both studies met the primary endpoint of PFS for patients whose tumours have common EGFR mutations receiving first-line Giotrif.2,3 In addition to new OS data, updated PFS data from the two trials will also be reflected in the updated European label, as will the significant improvements in lung cancer-related symptoms (cough, shortness of breath, pain) and quality of life observed with Giotrif compared to chemotherapy.1

Adverse events for Giotrif in the LUX-Lung 3 and 6 trials were as expected with EGFR inhibition and were predictable, manageable and reversible.1,2,3 Diarrhoea and rash/acne were the most frequently reported side effects with Giotrif therapy.1,2,3

NSCLC is the most common form of lung cancer comprising over 85% of lung cancer cases.4,5 EGFR mutation-positive NSCLC is a subtype of lung cancer. EGFR mutations are found in 10-15% of Caucasian and 40% of Asian patients with NSCLC.6 There are different types of EGFR mutations; the most common, which account for 90% of all EGFR mutations being del19 (approx. 50%) and L858R (approx. 40%).2,3 Afatinib, an oral, once daily ErbB family blocker, is currently approved in more than 60 countries for the first-line treatment of specific types of EGFR mutation-positive NSCLC (under brand names: Giotrif / Gilotrif).