Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

FDA approves Iressa for NSCLC

A new first-line therapy

Publish date:: July 21, 2015

On July 13, 2015, the US Food and Drug Administration approved both Iressa, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC), and a labeling expansion for therascreen EGFR RGQ PCR Kit, a companion diagnostic test for patient selection.

Indication: Iressa is indicated for the first-line treatment of patients with metastatic NSCLC whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.

Limitation of Use: Safety and efficacy of Iressa have not been established in patients with metastatic NSCLC whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations.

Dosage and Administration: The recommended dose of gefitinib is 250 mg orally once daily with or without food.

Citation: Iressa [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2015. http://www.azpicentral.com/iressa/iressa.pdf#page=1. Accessed July 16, 2015.

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