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FDA Grants Priority Review to Afatinib for NSCLC
A new drug application (NDA) for the investigational oncology compound afatinib (Boehringer Ingelheim) has been accepted for filing and granted priority review by the FDA. The application for afatinib is currently under review for the treatment of patients with locally advanced or metastatic non–small-cell lung cancer (NSCLC) with an epidermal growth factor receptor (EGFR) mutation, as detected by an FDA-approved test. The FDA target action date for afatinib has been set for the third quarter of 2013.
Recently, afatinib was also granted orphan drug designation. Currently there are no therapies specifically approved by the FDA for patients with locally advanced or metastatic NSCLC with an EGFR mutation.
Afatinib is an investigational, oral, once-daily irreversible ErbB protein family blocker that specifically inhibits EGFR (ErbB1), human epidermal receptor 2 (HER2 or ErbB2), and ErbB4. The drug is currently in phase III clinical development in advanced NSCLC, head-and-neck cancer, and breast cancer.
Source: Boehringer Ingelheim; January 15, 2013.