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Qiagen Gets FDA OK for Expanded Use of EGFR CDx for Lung Cancer Drug

NEW YORK (GenomeWeb) – Qiagen said today that the US Food and Drug Administration has extended the indications for use of its Therascreen EGFR RGQ PCR kit to guide the use of Boehringer Ingelheim's Gilotrif (afatanib) for first-line treatment of patients with metastatic non-small cell lung cancer harboring non-resistant EGFR mutations.

Specifically, FDA approved a premarket authorization supplement extending the labeling claim of the Therascreen kit to include detection of EGFR mutations L681Q, G719X, and S7681 to help identify NSCLC patients for whom Gilotrif is indicated.

On Jan. 12 the FDA expanded Gilotrif's approved indication to include treatment of NSCLC patients whose tumors have these EGFR mutations as detected by Therascreen in addition to the EGFR exon 19 deletions or exon 21 (L858R) substitution mutations for which it was approved in 2013.

"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," Jonathan Arnold, vice president and head of Qiagen's partnering for precision diagnostics unit, said in a statement.