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FDA approves Iressa for EGFR-mutated NSCLC
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The FDA today announced the approval of gefitinib for the first-line treatment of patients with metastatic non–small cell lung cancer whose tumors harbor specific epidermal growth factor receptor mutations.
The FDA also approved the therascreen EGFR RGQ PCR Kit (Qiagen) as a companion diagnostic test to identify patients whose tumors harbor EGFR mutations to determine which patients would benefit from treatment with gefitinib.
Richard Pazdur
Gefitinib (Iressa, AstraZeneca) is a kinase inhibitor that blocks proteins that promote the development of cancer cells with certain EGFR mutations. The current approval is intended for the treatment of patients with NSCLC and the most common types of EGFR mutations, including exon 19 deletions and exon 21 L858R substitution gene mutations.
Approximately 10% of patients with NSCLC harbor mutations in the EGFR gene, according to a press release from the FDA.
The FDA based its decision in part on results from a single-arm clinical trial of 106 patients with previously untreated EGFR mutation-positive metastatic NSCLC. Patients received daily treatment with gefitinib (250 mg per day). Approximately 50% of patients experienced tumor shrinkage, with responses lasting an average of 6 months.
Patients with exon 19 deletions and exon 21 L858R substitution mutations achieved similar response rates.
A retrospective analysis of another clinical trial — which enrolled 186 patients with EGFR mutation-positive metastatic NSCLC — confirmed gefitinib’s benefit, according to the press release. Researchers randomly assigned patients to receive gefitinib or up to six cycles of carboplatin and paclitaxel. The results suggested gefitinib improved PFS compared with carboplatin and paclitaxel.
Serious adverse events associated with gefitinib include interstitial lung disease, liver damage, gastrointestinal perforation, severe diarrhea and ocular disorders. Skin reactions are the most common adverse events associated with gefitinib.
In 2003, the FDA granted gefitinib accelerated approval for the treatment of patients with advanced NSCLC after progression on platinum doublet chemotherapy and docetaxel. The agent was voluntarily withdrawn from the market after subsequent clinical trials failed to verify its clinical benefit; however, this approval is for a different indication, for which it recently received orphan drug designation.
“Iressa offers another effective first-line therapy option for selected lung cancer patients,” Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “This approval provides further support for a highly targeted approach to treating cancer.”