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January 19, 2018

FDA Extends Approval for Qiagen NSCLC Test as CDx to Boehringer Ingelheim's Gilotrif

  • The FDA has granted Qiagen a Premarket Approval (PMA) supplement extending the authorization of Qiagen’s therascreen® EGFR RGQ PCR Kit as a companion diagnostic for Boehringer Ingelheim's targeted cancer treatment Gilotrif® (afatinib).

    The new indication expands the indications for therascreen to include detection of epidermal growth factor receptor (EGFR) mutations L681Q, G719X, and S768I, in order to identify non-small-cell lung cancer (NSCLC) patients for whom Gilotrif is indicated.

    “We are pleased to provide benefits to more lung cancer patients with these additional biomarkers in our clinically proven therascreen EGFR RGQ PCR Kit,” Jonathan Arnold, VP and head of Qiagen’s Partnering for Precision Diagnostics unit, said in a statement.

    “In addition to detecting the most comprehensive panel of EGFR mutations in which the safety and efficacy of Gilotrif have been established, the therascreen EGFR RGQ PCR Kit offers laboratories an efficient workflow on the Rotor-Gene® Q MDx, the real-time PCR module in our widely used QIAsymphony® family of instruments,” Arnold added.

    Gilotrif is a kinase inhibitor that was initially approved in 2013 as a first-line treatment for patients with metastatic NSCLC with common EGFR mutations as detected by an FDA-approved test. At the same time, the FDA approved therascreen as a companion diagnostic for Gilotrif.

    Gilotrif also won approval in 2016 for the additional indication of patients with metastatic squamous NSCLC progressing after platinum-based chemotherapy.

  • CDx for Two Lung Cancer Drugs

    Gilotrif is one of two lung cancer drugs for which the therascreen EGFR RGQ PCR Kit has been approved for use as a companion diagnostic. The other is AstraZeneca’s Iressa® (gefitinib), a tyrosine kinase inhibitor indicated for the first-line treatment of patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.

    Boehringer Ingelheim has not disclosed sales for Gilotrif, though GlobalData has projected they will reach $688.1 million by 2022

    The EGFR RGQ PCR Kit is a real-time PCR test intended for qualitative detection of exon 19 deletions and exon 21 (L858R) substitution mutations of the EGFR gene in DNA derived from formalin-fixed paraffin-embedded (FFPE) NSCLC tumor tissue—with the goal of distinguishing between EGFR mutation-negative (wild-type) and EGFR mutant tumors. 

    The kit includes reagents designed for rapid and sensitive detection of 21 somatic mutations of the human EGFR gene using the QIAamp® DSP DNA FFPE Tissue Kit and the Rotor-Gene Q MDx instrument.

    Boehringer Ingelheim and AstraZeneca are two of more than 25 biopharmas with which Qiagen is collaborating to develop companion diagnostic tests for drugs as of the end of 2017. This year, Qiagen has said it expects to generate more than five approval submissions to the FDA and/or U.S. launches.

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