FDA Grants Brigatinib Priority Review for ALK-Positive NSCLC

The FDA has has granted a priority review to a new drug application (NDA) for brigatinib for patients with metastatic ALK-positive non–small cell lung cancer (NSCLC) who are resistant to prior crizotinib (Xalkori), according to a statement from the drug’s developer, Ariad Pharmaceuticals. The NDA, which follows a breakthrough therapy designation that was received in October 2014, is based on findings from the phase II ALTA trial. In results from the trial presented at … (leggi tutto)