AstraZeneca's NDA For Iressa In EGFRm NSCLC Accepted By FDA

AstraZeneca reported that its recently submitted New Drug Application (NDA) for Iressa has been accepted by the U.S. Food and Drug Administration (FDA).

Iressa is an EGFR tyrosine kinase inhibitor that works by blocking signal transmission involved in tumor growth and spread. The drug was launched in 2002 and is currently approved in more than 90 countries for the treatment of adults with locally advanced or metastatic NSCLC with activating mutations of the EGFR tyrosine kinase.

The FDA accepted Iressa’s NDA as first line treatment for advanced or metastatic epidermal growth factor receptor mutation positive (EGFRm) non-small cell lung cancer (NSCLC) verified through a companion diagnostic test. The British drug firm is currently collaborating with Qiagen to develop a liquid biopsy-based companion diagnostic for Iressa> in NSCLC.

AZ’s application was supported by data from the late-stage study IFUM1 (IRESSA Follow-Up Measure) and IPASS2 (IRESSA Pan-ASia Study), which showed strong efficacy for the drug.

Earlier this year, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) also approved AstraZeneca’s application to update the drug’s EU label to include blood-based diagnostic testing. The company said it expects a Prescription Drug User Fee Act goal date for IRESSA to be in the third quarter of 2015.

Other companies that are developing treatments for NSCLC include Novartis, which received approval from the FDA for Zykadia this year as treatment for anaplastic lymphoma kinase-positive (ALK+) metastatic NSCLC. Bristol-Myers Squibb is also exploring combination treatments of nivolumab (brand name Opdivo) to treat patients with NSCLC.

Lung cancer is the leading cause of death due to cancer around the world. Of these, NSCLC is responsible for 85 to 90 percent of all cases. EGFR mutations take place in about 10 to 15 percent of NSCLC patients in Europe and 30 to 40 percent of NSCLC patients in Asia.