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FDA Approves Osimertinib for EGFR T790M-Positive NSCLC

Dr. Richard Pazdur

Richard Pazdur, MD

The FDA has granted an accelerated approval to osimertinib (Tagrisso, AZD9291) for patients with advanced EGFR T790M mutation-positive non–small cell lung cancer (NSCLC) following progression on a prior EGFR TKI.

The approval was based on data from 411 patients in two single-arm studies. In the first study, labeled AURA, the objective response rate (ORR) with osimertinib was 61% for those with EGFR T790M-mutant NSCLC. In the second trial, known as AURA2, the ORR was 57%, according to the FDA. Along with osimertinib, the FDA also approved the cobas EGFR Mutation Test v2 as a companion diagnostic.

“Our understanding of the molecular basis of lung cancer and reasons these cancers become resistant to prior treatments is rapidly evolving,” Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a statement. “This approval provides a new treatment for patients who test positive for the EGFR resistance mutation, T790M, and is based on substantial evidence from clinical trials that shows Tagrisso had a significant effect on reducing tumor size in over half of patients who were treated.” Click here to read the full article at

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