U.S. Food and Drug Administration (FDA) approved Iressa (gefitinib)

July 13, 2015


On July 13, 2015, the US Food and Drug Administration (FDA) approved Iressa (gefitinib) for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by a specific FDA-approved test. The drug is being approved concurrently with the use of this test, called  “therascreen EGFR RGQ PCR Kit” as a companion diagnostic. MGH Cancer Center researcher and lung cancer clinician Lecia Sequist, MD, who is a leader in the treatment of patients who have EGFR mutated lung cancer, is pleased that the drug is now approved for use in the setting of specific genetic alterations in EGFR. Dr. Sequist reacted to the news of the FDA decision, commenting, “It is wonderful to have Iressa (gefitinib) back in our armamentarium to treat EGFR mutation-positive lung cancer patients again. This development shows how much the field of lung cancer research and the FDA have advanced over the last 10 years, with a richer understanding of the strategy of matching the treatment to the tumor signature and the positive advances for patients that result in.” 

Media Contact: Katie Marquedant, (617) 726-0337, kmarquedant@partners.org