FDA approves new indication for AstraZeneca's Iressa, and companion diagnostic

The US Food and Drug Administration yesterday approved Anglo-Swedish pharma major AstraZeneca’s (LSE: AZN) Iressa (gefitinib) for the first-line treatment of 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.

Additionally, the therascreen EGFR RGQ PCR Kit, manufactured by Qiagen (Nasdaq QGEN), 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.

“Iressa offers another effective first-line therapy option for selected lung cancer patients. This approval provides further support for a highly targeted approach to treating cancer,” said Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.