FDA OKs Qiagen's companion Dx tool to lung-cancer drug

07/15/2013 | Genetic Engineering & Biotechnology News

The FDA has approved Qiagen's Therascreen EGFR assay as a companion diagnostic to determine which patients are eligible to receive Boehringer Ingelheim's Gilotrif. Gilotrif, or afatinib, is a newly approved drug for patients with metastatic nonsmall-cell lung cancer who have exon 21 L858R substitution mutations and exon 19 deletions in the EGFR gene.

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