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Jul 12, 2013

FDA Gives Nod to Boehringer NSCLC Drug, Qiagen CDx

  • Qiagen today said it has received FDA approval to market its Therascreen EGFR test as a companion diagnostic to guide use of Boehringer Ingelheim's newly approved Gilotrif™ (afatinib) for the first-line treatment of metastatic non-small-cell lung cancer (NSCLC) in patients whose tumors show certain EGFR gene mutations.

    The diagnostics firm said Therascreen EGFR helps clinicians identify EGFR mutation-positive patients eligible for treatment with afatinib, which is indicated for those who have EGFR exon 19 deletions and exon 21 L858R substitution mutations. According to Qiagen, each year around 120,000 metastatic NSCLC patients in the U.S. could benefit from testing for EGFR mutation.

    “Today’s approvals further illustrate how a greater understanding of the underlying molecular pathways of a disease can lead to the development of targeted treatments,” Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a statement. “Gilotrif is the second drug approved this year for patients with untreated metastatic NSCLC whose tumors have the EGFR exon 19 deletions or exon 21 L858R substitution mutations.”

    “The approval of companion diagnostic tests and drugs are important developments in oncology, as they help us bring safe and effective treatments to patients who need them,” added FDA Office of In Vitro Diagnostics and Radiological Health director Alberto Gutierrez, Ph.D.

    “We are very pleased to receive approval to market our Therascreen EGFR test in the United States, a successful outcome from our collaboration with Boehringer Ingelheim,” Qiagen CEO Peer Schatz said in a statement.

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