Gilotrif and Companion Diagnostic Approved for NSCLC

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The FDA announced the approval of Boehringer Ingelheim's Gilotrif (afatinib) for the treatment of metastatic non-small cell lung carcinoma (NSCLC) in patients whose tumors express specific types of epidermal growth factor receptor (EGFR) gene mutations as detected by an FDA-approved test. The FDA has also approved to market Qiagen N.V.'s therascreen EGFR RQG PCR kit as a companion diagnostic to guide the use of Gilotrif.

Afatinib is an oral once-daily tyrosine kinase inhibitor that specifically inhibits epidermal growth factor receptor (EGFR or ErbB1), human epidermal receptor 2 (HER2 or ErbB2) and ErbB4. It is intended for patients whose tumors express the EGFR exon 19 deletions or exon 21 L858R substitution gene mutations.

The safety and effectiveness of Gilotrif were established in a clinical study of 345 participants with metastatic non-small cell lung carcinoma whose tumors harbored EGFR mutations. Participants were randomly assigned to receive Gilotrif or up to six cycles of the chemotherapy drugs pemetrexed and cisplatin. Participants receiving Gilotrif had a delay in tumor growth (progression-free survival) that was 4.2 months later than those receiving chemotherapy.

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