New lung cancer pill TAGRISSO™ (AZD9291) from AstraZeneca , designed for patients whose disease has worsened after treatment with other therapies, won early U.S. FDA approval. FDA approved the once-daily tablet to treat a sub-set of patients with advanced non-small cell lung cancer earlier than expected: the official date for a decision was February 2016. AZD9291 is the only approved medicine indicated for patients with metastatic EGFR T790M mutation-positive non-small cell lung cancer. AZD9291 is an EGFR-TKI, a targeted cancer therapy, designed to inhibit both the activating, sensitising mutations (EGFRm), and T790M, a genetic mutation responsible for EGFR-TKI treatment resistance. The drug was granted Fast Track, Breakthrough Therapy, Priority Review and Accelerated Approval status by the FDA. The approval of TAGRISSO marks an important milestone for lung cancer patients who urgently need new treatment options.