FDA extends labelling for Therascreen EGFR RGQ PCR Kit in non-small cell lung cancer.- Qiagen.

Qiagen announced that the FDA has approved a PMA Supplement expanding the labelling claim of the Therascreen EGFR RGQ PCR Kit to allow its use as a companion diagnostic with Pfizer�s Vizimpro (dacomitinib) for first-line treatment of patients with non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or an exon 21 L858R mutation. The therascreen EGFR RGQ PCR kit is now approved as a companion diagnostic to guide the use of three FDA-approved therapies, including also Gilotrif (Afatinib) from Boehringer Ingelheim and Iressa (Gefitinib) from AstraZeneca.

Comment: More than 200,000 new lung cancer cases are diagnosed every year in the United States, with NSCLC accounting for approximately 85% of cases, leading to an estimated 160,000 deaths. Testing for EGFR mutations is believed to be the largest segment in companion diagnostics for personalized medicine.