FDA approves AstraZeneca’s Tagrisso

WILMINGTON, Del. — The Food and Drug Administration approved AstraZeneca’s Tagrisso (osimertinib) 80mg once-daily tablets, for the treatment of patients with metastatic epidermal growth factor receptor T790M mutation-positive non-small cell lung cancer.

According to AstraZeneca, Tagrisso is the first and only approved medicine in the United States indicated for NSCLC patients who have tested positive for the EGFR T790M mutation, and efficacy data suggest it may be a new standard of care for these patients.

 “By following the science, we aim to turn lung cancer into a chronic, manageable disease for patients and this milestone brings us one step closer to that ambition. The FDA’s full approval reinforces the potential of Tagrisso to become the standard of care for patients with metastatic EGFR T790M mutation-positive non-small cell lung cancer whose disease has progressed on or after first-generation EGFR-TKI therapy,” said Sean Bohen, EVP, Global Medicines Development and Chief Medical Officer at AstraZeneca.

The FDA approval is based on data from the randomized, Phase III AURA3 trial, in which TAGRISSO significantly improved progression-free survival (PFS) versus platinum-based doublet chemotherapy, providing 10.1 months of median PFS compared to 4.4 months from chemotherapy (hazard ratio 0.30; 70% risk reduction; 95% Confidence Interval [CI]: 0.23; 0.41; P<0.001). The results of this trial were recently presented at the 17th World Conference on Lung Cancer in Vienna, Austria, and published in The New England Journal of Medicine.