The FDA has granted Qiagen’s Therascreen EGFR RGQ PCR Kit approval for use as a companion cancer diagnostic for Pfizer’s Vizimpro, to identify non-small cell lung cancer patients with specific genetic mutations.
The expanded indication—for guiding first-line treatment for patients with epidermal growth factor receptor (EGFR) exon 19 deletions or an exon 21 L858R mutation—now allows the kit as a test for three FDA-approved NSCLC therapies, alongside Boehringer Ingelheim’s Gilotrif and AstraZeneca’s Iressa.
Mutations in the EGFR gene, changes that generally develop during a patient’s lifetime instead of being inherited, are estimated to be present in 10% to 35% of NSCLC cases globally, Qiagen said.
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The kit was developed through a collaboration between Qiagen and Pfizer, and was used in the pivotal clinical trial that earned Vizimpro’s concurrent FDA approval.
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The open-label study enrolled 452 patients and demonstrated a median progression-free survival of 14.7 months with Vizimpro (dacomitinib) compared to 9.2 months with Iressa (gefitinib).
“In addition to detecting a comprehensive panel of EGFR mutations, the Therascreen EGFR 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, Qiagen’s head of oncology and precision diagnostics, said in a statement.