The targeted agent Iressa (gefitinib) has been approved by the U.S. Food and Drug Administration (FDA) as initial therapy in the treatment of patients with advanced lung cancer.
Specifically, Iressa was approved as initial therapy for the treatment of patients with advanced non-small cell lung cancer (NSCLC) with specific mutations within the EGFR pathway.
The EGFR pathway is involved in cellular replication and spread. If there are mutations within the pathway, spread of cancer can remain uncontrolled.
EGFR inhibitors are agents that target specific points along the EGFR pathway. The agents reduce or minimize the spread of cancer cells that have mutations within the EGFR.
The latest approval of Iressa 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). The therascreen EGFR RGQ PCR Kit was approved as a companion diagnostic test to identify patients with tumors having the EGFR gene mutations in order to determine which patients would be appropriate for treatment with Iressa,” according to a press release by the U. S. FDA announcing the new approval.
This new approval provides another treatment option for patients with newly diagnosed NSCLC with specific mutations. Patients diagnosed with NSCLC should speak with their physician regarding their treatment options as therapy for NSCLC becomes more individually specialized.
Reference: United States Food and Drug Administration. FDA approves targeted therapy for first-line treatment of patients with a type of metastatic lung cancer. Companion test also approved to identify appropriate patients. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm454678.htm. Accessed July 14, 2015.
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