By
Diagnostics World Staff
July
13, 2015 | Today, the U.S. Food and Drug Administration announced its approval
of Iressa (gefitinib) for the first-line treatment of specific patients with
metastatic non-small cell lung cancer (NSCLC) whose tumors harbor specific
types of epidermal growth factor receptor (EGFR) gene mutations, as
detected by an FDA-approved test.
The
AstraZeneca drug is intended for the treatment of patients whose tumors express
the most common types of EGFR mutations in NSCLC (exon 19 deletions or exon 21
L858R substitution gene mutations). Approval of QIAGEN’s therascreen EGFR RGQ PCR Kit as a companion
diagnostic test will identify patients with tumors having the EGFR gene
mutations in order to determine which patients would be appropriate for
treatment with Iressa.
Lung cancer is the leading
cause of cancer-related death among men and women in the U.S. and, though more
common in men, the number of deaths from lung cancer in women is increasing.
According to the National Cancer Institute, an estimated 221,200 Americans will
be diagnosed with lung cancer, and 158,040 will die from the disease this year.
NSCLC is the most common type of lung cancer.
Iressa originally received
accelerated approval in 2003 for the treatment of patients with advanced NSCLC
after progression on platinum doublet chemotherapy and docetaxel, but was
voluntarily withdrawn from the market after subsequent confirmatory trials
failed to verify clinical benefit. The FDA later granted Iressa orphan product
designation for the treatment of EGFR mutation-positive metastatic NSCLC. Mutations
in the EGFR gene are present in about 10% of NSCLC tumors.
“The approval of the therascreen EGFR RGQ PCR Kit will allow physicians
to identify non-small cell lung cancer patients who are candidates for
receiving Iressa as first-line therapy,” said Alberto Gutierrez, Ph.D.,
director of the Office of In Vitro Diagnostics and Radiological Health in the
FDA’s Center for Devices and Radiological Health in the announcement.
“Companion diagnostics provide information that is essential for the safe and
effective use of important medications.”