FDA Grants Priority Review for Osimertinib as Treatment for Early-Stage EGFR-Mutated Lung Cancer

By Adam Hochron
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The FDA has granted priority review for osimertinib as an adjuvant treatment for early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumor resection. 

According to a release from the manufacturer, the supplemental New Drug Application was filed based on the results of the phase III ADAURA trial, which showed the treatment improved disease-free survival for patients with Stage II and IIIA EGFRm, as well as patients with Stage IB-IIIA disease. In April of this year, an Independent Monitoring Committee recommended the trial be unblinded two years early “based on its determination of overwhelming efficacy,” the release noted. Results of the trial were presented at the ASCO Virtual Scientific Program and published in the New England Journal of Medicine. The full data was expected to be ready in 2022, with the trial is continuing to assess overall survival. 

“Patients with early-stage EGFR-mutated lung cancer are still at considerable risk of recurrence after surgery and adjuvant chemotherapy, and new targeted treatment options are critical to improving outcomes for these patients,” said Dave Fredrickson, Executive Vice President, Oncology Business Unit. “This expedited review underscores the unprecedented disease-free survival benefit Tagrisso brings to patients in the adjuvant setting, and we will continue working with the FDA to provide this practice-changing treatment to patients as quickly as possible.” 

Osimertinib received Breakthrough Therapy Designation in July and is approved as a first-line treatment for patients with locally advanced or metastatic EGFRm NSCLC and as a treatment for locally advanced or metastatic EGFR T790M mutation-positive NSCLC. 


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