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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, in non-small cell lung cancer ( NSCLC ).

The CHMP recommendation includes data from the LUX-Lung 3 and 6 trials which have shown 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 Afatinib compared to standard chemotherapy ( overall survival; OS = secondary endpoint, progression-free survival; PFS = primary endpoint ).

Following CHMP positive opinion, the European prescribing information has been updated to include additional data from LUX-Lung 3 and LUX-Lung 6.
Both studies met the primary endpoint of progression-free survival for patients whose tumours have common EGFR mutations receiving first-line Giotrif.
In addition to new overall survival data, updated progression-free survival data from the two trials were included.

Significant improvements in lung cancer-related symptoms ( cough, shortness of breath, pain ) and quality of life observed with Giotrif compared to chemotherapy were seen.

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

Non-small cell lung cancer is the most common form of lung cancer comprising over 85% of lung cancer cases. 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.
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% ).

Afatinib, an oral, once daily ErbB family blocker. ( Xagena )

Source: Boehringer Ingelheim, 2015

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