QIAGEN NV, Hilden, Germany, with US headquarters in Germantown, Md, has submitted its therascreen® EGFR RGQ PCR Kit (therascreen EGFR test) to the FDA as a proposed companion diagnostic to guide treatment with afatinib, a new investigational oncology compound developed by Link no longer available, Ingelheim, Germany.
Afatinib has been accepted for filing and granted Priority Review by the FDA as a proposed treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with an epidermal growth factor receptor (EGFR) mutation detected by an FDA-approved test.
“When approved, the therascreen EGFR test will enable doctors to make informed treatment decisions for many cancer patients. Submission of therascreen EGFR test, which runs on Rotor-Gene Q, is another milestone for our personalized health care franchise,” says Peer M. Schatz, CEO, QIAGEN. “We continue to advance our strategic initiative to add new test content by seeking regulatory approval for diagnostic kits to run on modules of the QIAsymphony family.
QIAGEN submitted a Premarket Approval (PMA) application for use of the therascreen EGFR test to determine which NSCLC patients would be potentially eligible for treatment with afatinib.
The companion diagnostic was developed in collaboration with Boehringer Ingelheim. In September 2012, the proposed drug was also submitted to the European Medicines Agency (EMA). A version of the therascreen EGFR test has already been CE-marked and is available for diagnostic use in Europe. In late 2011, the test received regulatory approval in Japan, the world’s second largest market for personalized health care, according to the company.
QIAGEN markets in Europe additional therascreen assays for biomarkers including NRAS, BRAF, PI3K, JAK2, MGMT, and UGT1A1. A range of biomarker assays and related sample and assay technologies also are marketed to customers globally for use during the research and development of new medicines.
|Lung cancer is the deadliest form of cancer. More than 200,000 new lung cancer cases in the United States and 391,000 in Europe are diagnosed each year, leading to an estimated 160,000 deaths in the United States and 340,000 in Europe. NSCLC accounts for about 85% of all lung cancer cases. Tumors in 10% to 15% of Caucasians and about 40% of Asians with NCSLC have mutations involving EGFR, a protein found on the surface of cells. EGFR mutations can lead to its constant activation (or over-expression), which is associated with uncontrolled cell division and development of advanced NSCLC. The submission of the afatinib registration is supported by the findings of Boehringer Ingelheim’s LUX-Lung 3 study, the largest Phase III trial conducted to date in untreated patients with locally advanced or metastatic NSCLC with a confirmed EGFR mutation-positive status, using the therascreen EGFR test. [Source: QIAGEN]
[Source: QIAGEN NV]